MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC RED FORCEPS POINTS NARROW-RATCHET 132

Model Number 398.40

Device Problems Break (1069); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Additional narrative: initial reporter occupation: reporter is a j&j sales representative.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 Description

It was reported that on an unknown date, while putting a set together in sterile processing it was noticed that this reduction forceps was bent and did not close properly.Broken point to point reduction clamp.There was no patient involvement.This complaint involves one device.This report is for (1) red forceps points narrow-ratchet 132.This report is 1 of 1 for (b)(4).

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.H10 additional narrative: updated data: h4.Investigation summary visual inspection: the reduction forceps with points narrow-ratchet 132mm (part # 398.40, lot #: t189990) was returned and received at us cq.Upon visual inspection, the distal tip of one of the jaws was observed to be bent and deformed.Also, the tip was observed to be nicked but has no impact on the functionality of the device.Device failure/defect identified? yes.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Furthermore, the complaint relevant dimensions cannot be checked for dimensional accuracy, because of the design of the device.Document/specification review.The relevant current and manufactured revision of drawings were reviewed reduction forceps (current)/(manufactured).Complaint confirmed? yes.Investigation conclusion.The complaint condition is confirmed as the received device was bent.There is no indication that a design or manufacturing issue has caused the issue 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 history lot.Part number: 398.40.Lot number: t189990.Manufacturing site: tuttlingen.Release to warehouse date: 17-dec-2019.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.The raw material certificate was reviewed and the used material was according to the specification of the device.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.Corrected data: g1, h3, h6.

• Brand Name: RED FORCEPS POINTS NARROW-RATCHET 132
• Type of Device: FORCEPS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12026609
• MDR Text Key: 268067319
• Report Number: 2939274-2021-03050
• Device Sequence Number: 1
• Product Code: HTD
• UDI-Device Identifier: 10886982201355
• UDI-Public: (01)10886982201355
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/25/2021

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
• Device Operator: Health Professional
• Device Model Number: 398.40
• Device Catalogue Number: 398.40
• Device Lot Number: T189990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2021
• Initial Date Manufacturer Received: 05/25/2021
• Initial Date FDA Received: 06/18/2021
• Supplement Dates Manufacturer Received: 06/23/2021
• Supplement Dates FDA Received: 07/21/2021
• Patient Sequence Number: 1