MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TEMPORARY FIXATION PIN-LONG; MISC ORTHO SURGICAL INSTR

Model Number	03.661.125
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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.
Event or Problem Description
It was reported that on (b)(6) 2019, during insertion of a temporary fixation pin-long, the threaded tip broke off the shaft of the instrument.It was removed using a biting rongeur.The procedure was successfully completed with a delay of three (3) minutes due to the removal of a broken tip.Fragments were easily removed.No patient consequence.This is report 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.Part: 03.661.125; synthes lot: 6607691; supplier lot: 6607691; release to warehouse date: may 31, 2011; supplier: (b)(4).No nonconformance reports (ncrs) were generated during production.The raw material was confirmed to be correct per the specification with no (relevant) non-conformance noted.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Visual inspection: temporary fixation pin-long was received at customer quality (cq).Upon visual inspection at cq, it is observed that the threaded tip of the shaft is broken.The complaint is confirmed.The remaining portions of the device show normal wear consistent with use.The broken threaded tip was also received at cq.Dimensional inspection: dimensional inspection cannot be performed due to post manufacturing damage.Document/ specification review: the following drawing(s) was reviewed; - fixation pin temporary, long no design issues or discrepancies were found during this investigation.Investigation conclusion: this complaint is confirmed.Visual inspection and document specification review of the received device was performed at cq.A definitive root cause could not be determined.It is possible that the device may have encountered unintended forces.During the investigation, no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.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-LONG
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8695994
• Report Number: 2939274-2019-58629
• Device Sequence Number: 14014828
• Product Code: LXH
• UDI-Device Identifier: 10705034721217
• UDI-Public: (01)10705034721217
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2019

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 Model Number: 03.661.125
• Device Catalogue Number: 03.661.125
• Device Lot Number: 6607691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2019
• Initial Date Received by Manufacturer: 05/15/2019
• Supplement Date Received by Manufacturer: 06/26/2019
• Initial Report FDA Received Date: 06/13/2019
• Supplement Report FDA Received Date: 07/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR