MAUDE Adverse Event Report: DEPUY MITEK LLC US BIOCRYL INTSCR 8X23MM *EA; ORTHOPAEDIC BONE SCREW, BIOABSORBABLE

Model Number	231710
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported by the customer in (b)(6) that during an anterior cruciate ligament procedure on (b)(6) 2020, it was observed that the screw device broke.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting d mitek or its emplo the devt e, mitek, or its employees caused or contri uteicto the po,ential eemnloyees caused or contributed if informatioa ievent described in this report.If information is obtained that was not available for thermation is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Additional information: b5: subsequent follow-up with the customer, additional information was received.It was reported that an alternative product was readily available but the procedure was not completed.It was reported that there were no fragments generated and no surgical intervention planned.The event description has been updated accordingly.
Event or Problem Description
It was reported by the customer in brazil that during an anterior cruciate ligament procedure on (b)(6) 2020, it was observed that the screw device broke.It was reported that an alternative product was readily available but the procedure was not completed.It was reported that there were no fragments generated and no surgical intervention planned.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, 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 = according to the information provided, it was reported that the screw broke during the surgical procedure.The device was received and evaluated.Visual observations reveals that the device is broken on the distal tip.A manufacturing record evaluation was performed for the finished device 6l35953 number, and no non-conformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.According with the visual inspection result, this complaint can be confirmed.The possible root cause can be attributed to the handling of the device, a bad bone preparation or a misaligned axis at the moment of the insertion, however this cannot be conclusively determined.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, 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.H10 additional narrative: d9, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Common Device Name: ORTHOPAEDIC BONE SCREW, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11101728
• Report Number: 1221934-2020-04176
• Device Sequence Number: 19843017
• Product Code: MAI
• UDI-Device Identifier: 10886705010608
• UDI-Public: 10886705010608
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/17/2020

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: 09/30/2022
• Device Model Number: 231710
• Device Catalogue Number: 231710
• Device Lot Number: 6L35953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2020
• Supplement Date Received by Manufacturer: 01/07/2021; 04/06/2021; 04/07/2021
• Initial Report FDA Received Date: 12/31/2020
• Supplement Report FDA Received Date: 01/08/2021; 04/07/2021; 04/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1