MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CERCLAGE PASSER, DIVIDABLE FORCEPS, SMALL; MISC ORTHO SURGICAL INSTRUMENT

Catalog Number	03.221.010
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device received.(b)(6).Synthes sales consultant.A review of the device history records has been requested.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.The investigation could not be completed; no conclusion could be drawn, as no product was received.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
Device report from synthes reports an event in (b)(6) as follows: bq received a damaged device 03.221.010, lot 9627873 from the customer.Issue reported end/tips not aligned 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.Device history records review was completed for part: 03.221.010, lot: 9627873.Manufacturing location: synthes umkirch germany, release to warehouse date: nov 02, 2015.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Product investigation was completed.Cercl-passer ø46 min-invasive was received.Upon visual inspection, cercl-passer was identified to be deformed and the tips were not aligning with each other.Thus, the reported complaint was confirmed.The surface of the device shows minor wear with consistent use over 3 years.Due to the post manufacturing damage (deformation), it is not possible to verify the relevant dimensions of the device.Relevant drawings were reviewed during the investigation.Visual inspection and document review were performed during the investigation.Though definitive root cause cannot be determined, repeated use and service might have contributed to the complaint condition.This complaint is confirmed however no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.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.
Event or Problem Description
It was reported on an unknown date, bq-synthes received a damaged cerclage passer with an end/tips not aligned.It is unknown if when was the issue discovered.It is unknown if there were patient and procedure involvement.

• Brand Name: CERCLAGE PASSER, DIVIDABLE FORCEPS, SMALL
• Common Device Name: MISC ORTHO SURGICAL INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8467087
• Report Number: 2939274-2019-57196
• Device Sequence Number: 1019622
• Product Code: LXH
• UDI-Device Identifier: 07611819880092
• UDI-Public: (01)07611819880092
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• 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
• Report Date (Section B): 03/06/2019

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 Catalogue Number: 03.221.010
• Device Lot Number: 9627873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2019
• Initial Date Received by Manufacturer: 03/06/2019
• Supplement Date Received by Manufacturer: 04/24/2019
• Initial Report FDA Received Date: 03/29/2019
• Supplement Report FDA Received Date: 05/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1