MAUDE Adverse Event Report: DEPUY MITEK LLC US MILAGRO INTSCR 8X30MM *EA; ORTHOPAEDIC BONE SCREW, BIOABSORBABLE

Catalog Number	231815
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Material Twisted/Bent (2981)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Injury (2348); Not Applicable (3189)
Date of Event	12/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported by the affiliate in the (b)(6) that during acl (ant cruciate ligament) reconstruction surgical procedure, it was observed that the milagro intscr 8x30mm *ea screw thread was deformed.It was not reported if there was a delay in the surgical procedure, or if a spare device was available for use.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Upon further review of the complaint, it was determined that the previously reported serious injury is unlikely to cause or contribute to patient harm.Therefore, this complaint is determined to be a malfunciton.If additional information should become available, a supplemental medwatch will be submitted accordingly.
Additional Manufacturer Narrative
Product complaint # : (b)(4).Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the complaint device is unavailable for a physical evaluation, nor were pictures provided.Hence, this complaint cannot be confirmed.The information provided is not sufficient to determine a root cause for the reported failure.However, if any additional information is obtained, this complaint will be re-opened to capture that information.Furthermore, a non-conformance search was conducted and no non-conformances were identified for this part number (231815), lot number (3928266) combination.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthese mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.Udi:(b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.Hence, this complaint cannot be confirmed.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.If any additional information is obtained, this complaint will be re-opened to capture that information.Furthermore, a non-conformance search was conducted and no non-conformances were identified for this part number (231815), lot number (3928266) combination.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.Udi:(b)(4).
Additional Manufacturer Narrative
Product complaint #: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Additional information received from affiliate stating that the event occurred intra-operative.There was a delay of 10 minutes.There was no patient impact due to the delay.The same bone hole was used to complete the procedure.A different readily available device was used to complete the procedure.The device will be returning for evaluation.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.Hence, this complaint cannot be confirmed.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.If any additional information is obtained, this complaint will be re-opened to capture that information.Furthermore, a non-conformance search was conducted and no non-conformances were identified for this part number (231815), lot number (3928266) combination.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.Udi:(b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Investigation summary: the complaint device was received and inspected.The complaint can be confirmed.It was observed that the device was broken in two pieces, and the distal tip of the device had tissue debris covering the threads.The threads of the distal tip were heavily deformed.Anchor breakages and thread deformation are typically associated with off axis insertion, levering during insertion, hard bone quality or using incorrect instrumentation for preparing bone hole.The device may have migrated out of the bone hole due to the threads being excessively worn.However, given the information provided we cannot discern a definitive root cause for the reported failure.A non-conformance search was conducted to investigate any defects identified during production that may contribute to the complaint condition.Non-conformance were raised during the processing of this lot, however were unrelated to the complaint condition.At this point, no corrective action is required and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.Hence, this complaint cannot be confirmed.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.If any additional information is obtained, this complaint will be re-opened to capture that information.Furthermore, a non-conformance search was conducted and no non-conformances were identified for this part number (231815), lot number (3928266) combination.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.Correction: (adverse event): additional information received on 01/11/2019 from the affiliate via email reporting that an adverse event occurred to the patient during the procedure on (b)(6)2018.The affiliate reported that the acl slipped from the bone during the procedure.The procedure was completed by opening other stocks of the device.
Event or Problem Description
Additional information received on 01/11/2019 from the affiliate via email reporting that an adverse event occurred to the patient during the procedure on (b)(6)2018.The affiliate reported that the acl slipped from the bone during the procedure.The procedure was completed by opening other stocks of the device.

• Common Device Name: ORTHOPAEDIC BONE SCREW, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8196583
• Report Number: 1221934-2018-55832
• Device Sequence Number: 13515938
• Product Code: MAI
• UDI-Device Identifier: 10886705010783
• UDI-Public: 10886705010783
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: 231815
• Device Lot Number: 3928266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2019
• Initial Date Received by Manufacturer: 12/11/2018
• Supplement Date Received by Manufacturer: 01/10/2019; 01/11/2019; 01/16/2019; 01/10/2019; 02/21/2019; 03/13/2019; 03/22/2019
• Initial Report FDA Received Date: 12/26/2018
• Supplement Report FDA Received Date: 01/10/2019; 01/11/2019; 01/16/2019; 02/04/2019; 02/21/2019; 03/22/2019; 03/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1