MAUDE Adverse Event Report: DEPUY MITEK LLC US 6X12 MILAGRO INTERFRENCE SCREW; ORTHOPAEDIC BONE SCREW, BIOABSORBABLE

Catalog Number	231813
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.(b)(4)-incomplete the lot number is currently unavailable; therefore, the exp date is unavailable.The complaint device is not being returned as it was discarded by the customer; therefore, this complaint cannot be confirmed and duplicated.The assignable root cause was not determined.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 sales rep via phone that during a fhl transfer procedure, it was observed that milagro interference screw 6x12mm device broke mid-body while being inserted.The sales rep stated that the hole had been drilled and the screw broke while being tapped in.The screw was removed with no debris left behind.The case was completed with a new screw in the same bone hole with no patient harm or delay.The device was discarded by the customer.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
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.Further, no lot numbers were supplied which precludes conducting a device history record (dhr) review or a lot specific search in the complaints handling system.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.At this point in time, no corrective action is required, and no further action is warranted.However, (b)(4) 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.(b)(4).Depuy synthes has been informed that the lot number is not available.
Event or Problem Description
Additional information received from sales representative on (b)(6) 2018: the lot number was proved as 3914932; however, the consignment team indicated the lot provided was invalid.There were no procedural or patient anatomy factors which may have contributed to the breakage.The patient¿s bone quality was noted as normal.The insertion was not off axis.The same bone hole was used to complete the procedure.The tunnel and graft size were six millimeters (6mm).No trialing was performed.
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.A non-conformance search was performed for this part (231813) and lot (3914532) combination and no non-conformances were identified.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.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.(b)(4).

• Brand Name: 6X12 MILAGRO INTERFRENCE SCREW
• Common Device Name: ORTHOPAEDIC BONE SCREW, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8033071
• Report Number: 1221934-2018-55164
• Device Sequence Number: 1643204
• Product Code: GEI
• UDI-Device Identifier: 10886705021956
• UDI-Public: 10886705021956
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K143660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 231813
• Device Lot Number: 3914532
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/15/2018
• Supplement Date Received by Manufacturer: 10/31/2018; 11/07/2018
• Initial Report FDA Received Date: 11/02/2018
• Supplement Report FDA Received Date: 11/07/2018; 11/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1