MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PELVIC ARM 225MM; FORCEPS

Model Number	398.753
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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) 2021, before a procedure, a part from the collinear set was broken.This was discovered pre-operatively.There was no patient involvement.This report is for a pelvic arm.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: 398.753, lot: 11-2340, manufacturing site: selzach, supplier: leitner ag, release to warehouse date: april 11, 2012.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Visual inspection: the complaint device pelvic arm was returned to customer quality (cq), west chester for investigation.The lock assembly had broken and was received detached from the housing and the buckle.There were no other issues on the pelvic arm that could have contributed to the complaint condition.The overall complaint condition could be confirmed.Document/specification review: according to the date of manufacture, the current and manufacturing drawings of the part were reviewed: pelvic arm, current and manufactured revisions.Swinglock, current and manufactured revisions.Shaft, current and manufactured revisions.Dimensional inspection: as per swinglock, (manufactured revision) and shaft, (manufactured revision).Specified dimension.Shaft pin diameter.Swinglock shaft thickness.Measured dimensions: shaft pin diameter: confirming.Swinglock shaft thickness: confirming.Measurement device used: caliper.Complaint confirmed: yes, the overall complaint condition of broken can be confirmed.Investigation conclusion: the pelvic arm was found broken near locking mechanism during investigation.The device had been in use since 2012 and this may have contributed to the failure of the device, but a definitive assignable root cause could not be determined.There was no indication that a design or manufacturing issue contributed to the complaint and no design issues were observed during the document/specification review.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: PELVIC ARM 225MM
• Common Device Name: FORCEPS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12283085
• Report Number: 2939274-2021-04512
• Device Sequence Number: 19532015
• Product Code: HTD
• UDI-Device Identifier: 10886982201577
• UDI-Public: (01)10886982201577
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2021

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: 398.753
• Device Catalogue Number: 398.753
• Device Lot Number: 11-2340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2021
• Initial Date Received by Manufacturer: 07/09/2021
• Supplement Date Received by Manufacturer: 08/17/2021
• Initial Report FDA Received Date: 08/05/2021
• Supplement Report FDA Received Date: 09/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1