MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HOLDING FORCEPS

Model Number 351.782

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Reporter is a j&j employee.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, during a routine incoming inspection of a loaner set at fsl ups (b)(6) site, it was observed that a holding forceps was broken.There was no known patient or hospital involvement.This report is for one (1) holding forceps.This is report 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.H3, h6: part: 351.782, lot: 5016028, manufacturing site: unknown, release to warehouse date: unknown.Part/lot combination are unknown at synthes tuttlingen gmbh, no device history record (dhr) review possible.Visual inspection: the holding forceps was received at us customer quality (cq).Upon visual inspection, it is seen that one of the handles of the holding forceps was broken.Hence, the reported condition is confirmed.The device shows normal wear consistent with use.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Document/specification review: the following drawing was reviewed: holding forceps investigation conclusion the complaint condition was confirmed for the holding forceps as it was broken.There is no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.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: HOLDING FORCEPS
• Type of Device: FORCEPS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10535938
• MDR Text Key: 207066831
• Report Number: 2939274-2020-04128
• Device Sequence Number: 1
• Product Code: HTD
• UDI-Device Identifier: 10886982193995
• UDI-Public: (01)10886982193995
• 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
• Type of Report: Initial,Followup
• Report Date: 08/19/2020

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
• Device Operator: Health Professional
• Device Model Number: 351.782
• Device Catalogue Number: 351.782
• Device Lot Number: 5016028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2020
• Initial Date Manufacturer Received: 08/19/2020
• Initial Date FDA Received: 09/15/2020
• Supplement Dates Manufacturer Received: 09/17/2020
• Supplement Dates FDA Received: 10/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1