MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PLATE HOLDING FORCEPS WITH SWIVEL FOOT/SIZE 0

Model Number	398.811
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
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 an unknown date, the plate holding forceps with swivel foot was found broken upon opening the package at the hospital.The swivel foot was not attached to the forceps.It appears to be missing the pin that holds it in place.This item has not been used or sterilized.There was no patient involvement.This report is for a plate holding forceps.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.Concomitant medical products: received at final destination.A review of the device history record: part number: 398.811.Lot number: t169586.Manufacturing site: tuttlingen.Release to warehouse date: 28-jan-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.Investigation summary background: it was reported that on an unknown date, the plate holding forceps with swivel foot was found broken when arrived to the hospital upon opening the package.The swivel foot was not attached to the forceps.It appears to be missing the pin that holds it in place.This item has not been used or sterilized.There was no patient involvement.This complaint involves one (1) device.Investigation flow: visual.Visual inspection: the plate holding forceps with swivel foot was received at the us cq partially disassembled.The swivel foot and pivot block subcomponents were received detached from the main assembly.The pin used to hold them in place was not returned.During the manufacturer evaluation, it was observed that the missing pin was supposed to be welded during manufacturing, but no signs of welding were present on the device.No other issues could be identified with the returned portions of the device.Document/specification review: drawing(s) reviewed: (current & manufactured revision).Plate holding forceps w/swivel foot, size 0; 398-811 rev j.Manufacturing record evaluation: the received device (part # 398.811 lot # t169586) was manufactured at the tuttlingen site on 28 january 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.Dimensional inspection: a dimensional inspection was not performed due to the device conclusively missing a component.Conclusion: the complaint was confirmed for the plate holding forceps with swivel foot.The swivel foot and pivot block subcomponents had detached from the main assembly because a pin (subcomponent pin 2) was missing and not returned with the rest of the device.The manufacturer evaluation confirmed that the pin was not welded on during manufacturing, which allowed it to fall out at an unknown time.The device, however, is not confirmed as broken, since all returned portions are in good condition.There was no indication that a design issue contributed to the complaint.No design issues were observed during the document/specification review.The root cause was traced back to manufacturing.The welding operation failed to weld pin 2 to the device.Based on the investigation findings, 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: PLATE HOLDING FORCEPS WITH SWIVEL FOOT/SIZE 0
• Common Device Name: FORCEPS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8650063
• Report Number: 2939274-2019-58360
• Device Sequence Number: 16665700
• Product Code: HTD
• UDI-Device Identifier: 10886982201676
• UDI-Public: (01)10886982201676
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Report Date (Section B): 04/29/2019

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 Model Number: 398.811
• Device Catalogue Number: 398.811
• Device Lot Number: T169586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2019
• Initial Date Received by Manufacturer: 04/29/2019
• Supplement Date Received by Manufacturer: 06/27/2019
• Initial Report FDA Received Date: 05/29/2019
• Supplement Report FDA Received Date: 06/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1