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

Catalog Number	231821
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(6).Udi: (b)(4).
Event or Problem Description
It was reported by the affiliate via email that the 8x30 milagro advance screw broke when screwed into the channel.
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.H10 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 was received and evaluated.Upon visual inspection the part appear to be sheared and incomplete.The complaint is confirmed.A possible root cause for the screw to be sheared could possibly be attributed to excessive force applied while inserting the screw.Given the information provided in the description of the event, a definite root cause could not be established.A manufacturing record evaluation was performed for the finished device 231821 lot 2l06390, and no non-conformances were identified.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).
Event or Problem Description
Additional information provided by the affiliate reported the event occurred during an acl reconstruction and no patient consequences were observed, the affiliate stated the procedure was completed with another readily available milagro screw.It was also reported the initial screw broke into 2 pieces but only half was removed.The other half stayed in the patient, fixed to the cruciate.The affiliate reported the doctor was not off axis, the patient had good bone quality, and the same bone hole was utilized to complete the procedure.It was also reported surgical intervention is not planned.
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.H10 additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: MILAGRO ADVANCE SCREW 8X30MM
• Common Device Name: ORTHOPAEDIC BONE SCREW, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8723260
• Report Number: 1221934-2019-57394
• Device Sequence Number: 13885467
• Product Code: HWC
• UDI-Device Identifier: 10886705022267
• UDI-Public: 10886705022267
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K123362
• 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
• Report Date (Section B): 05/27/2019

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: 10/31/2021
• Device Catalogue Number: 231821
• Device Lot Number: 2L06390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2019
• Initial Date Received by Manufacturer: 05/27/2019
• Supplement Date Received by Manufacturer: 06/27/2019; 08/14/2019
• Initial Report FDA Received Date: 06/21/2019
• Supplement Report FDA Received Date: 07/24/2019; 08/15/2019
• Patient Sequence Number: 1