MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PELVICREDUCFORCEPS LRG ADJUST SPEED-LOCK

Model Number	398.88
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
It was reported that on an unknown date, the large pelvic reduction forceps were broken.The issue was discovered after the reported device was returned in a flash pan with the other instruments used in an open reduction internal fixation (orif) acetab procedure on (b)(6) 2020.It was mentioned that the device worked correctly during the procedure and had no issues until the instruments were put back into their sets for the next surgery.There was no patient adverse consequence reported.This report is for one (1) pelvicreducforceps lrg adjust speed-lock.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).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.D10: device returned.H3, h4, h6: a review of the device history record.Device history lot: part number: 398.880.Lot number: 6035.Manufacturing site: salzburg.Release to warehouse date: 08.Mar.2002.Dhr not available as device is older than 17 years.At this time the manufacturing documents for instruments had to be stored for 10 years.This was according to se-075477 (filing and archiving of specification documents) version ai, which was in place till august 2014.H3, h6: investigation summary background: it was reported on an unknown date, the large pelvic reduction forceps was noticed to have something broken or missing on it.The issue was discovered after the reported device was returned in a flash pan together with the other instruments after an open reduction internal fixation (orif) acetab procedure on (b)(6) 2020.It was mentioned that the device worked correctly during the case and had no issues only until the instruments were put back into their sets for the next surgery.It is unknown when and how the issue happened.There was no patient adverse consequence reported.This complaint involves one (1) device.Service and repair evaluation: the customer reported the device had something broken or missing.The repair technician reported two arm are disassembled and the screws are missing.Missing parts is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item will be forwarded to customer quality.The evaluation was confirmed.Investigation flow: damage.Visual inspection: the pelvic reduce forceps lrg adjust speed-lock (p/n: 398.880, lot number: 4438408) was received at us cq.Upon visual inspection, the device is missing the screw that holds the halves together.Upon drawing review, the screws are welded.Therefore, for the screws to be missing, the welds must have broken.Dimensional inspection: no dimensional inspection was performed due to post-manufacturing damage and the definitive finding of a missing component.Document/specification review: se_623681 rev d (current) and 398_88 rev a (manufactured) were reviewed.No design issues or discrepancies were identified.Investigation conclusion: this complaint is confirmed as the screw is missing and the welds are broken.No definitive root cause could be determined based on the provided information.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.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.H11: g1: updated manufacturing site name provided for reporting.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.
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.H3, h6: 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.

• Brand Name: PELVICREDUCFORCEPS LRG ADJUST SPEED-LOCK
• Common Device Name: FORCEPS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9623621
• Report Number: 2939274-2020-00385
• Device Sequence Number: 16794959
• Product Code: HTD
• UDI-Device Identifier: 10886982201928
• UDI-Public: (01)10886982201928
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/03/2020

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 Model Number: 398.88
• Device Catalogue Number: 398.880-US
• Device Lot Number: 4438408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2020
• Initial Date Received by Manufacturer: 01/02/2020
• Supplement Date Received by Manufacturer: 02/10/2020; 02/21/2020
• Initial Report FDA Received Date: 01/23/2020
• Supplement Report FDA Received Date: 02/14/2020; 02/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 22 YR