MAUDE Adverse Event Report: SYNTHES GMBH TEMPORARY FIXATION PIN; BENDER

Model Number	03.161.057
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a procedure on (b)(6) 2023, the temp fix pin broke inside the patient.Procedure was completed successfully with no delay.This report is for a temporary fixation pin.This report is 1 of 1 for (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h6: a manufacturing record evaluation cannot be performed due to lot number being unknown.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the device from the received image(s).Visual analysis of the photo revealed that temporary fixation pin had broke from the threads.The broken fragment is not visible in the evidence provided.As there were no x-rays provided, is not possible to confirm the embedded device condition.No other issues were found.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for temporary fixation pin.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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.

• Brand Name: TEMPORARY FIXATION PIN
• Common Device Name: BENDER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16797387
• Report Number: 8030965-2023-05177
• Device Sequence Number: 6386698
• Product Code: HXW
• UDI-Device Identifier: 10705034711720
• UDI-Public: (01)10705034711720
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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 Model Number: 03.161.057
• Device Catalogue Number: 03.161.057
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/06/2023
• Initial Report FDA Received Date: 04/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Patient Sex: Male