MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TERMITE FORCEPS 90MM

Catalog Number	398.95
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no known reported patient involvement associated with the complained event.Unknown when device malfunctioned.Device is an instrument and is not implanted/explanted.(b)(4).The subject device has been received and the product evaluation is in progress.No conclusion can be drawn.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 during processing the customer discovered the tip/point of the termite forceps 90mm was broken.No surgery or patient involvement.This is report 1 of 1 for complaint (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.Corrected data: (udi).A device history record review was performed for the subject device: part number: 398.95.Synthes lot number: t945722.Release to warehouse date: 23-apr-2010.Manufacture site: synthes tuttlingen.Part expiration date: n/a.List of nonconformance¿s: #115447.A review of the device history records showed that there were no issues at the time of manufacturing of this device and it's sub components that would contribute to the complaint condition.An ncr was started according to local nc procedures for four scrapped parts.The parts were scrapped because of tests performed on the spot welds to secure the pivot screw.The nc has no relevance to the complaint issue.A product development investigation was performed for the subject device: the termite forceps (part: 398.95, lot: t945722, mfg: 23-apr-2010) was inspected at customer quality and the complaint of broken tip was confirmed.Upon visual inspection, it is observed that tip of the one of the forceps handle was broken.Broken fragments were not returned.No new malfunctions have been identified.Whether this complaint could be replicated is not applicable because the device was returned broken.Relevant drawings for the returned device were reviewed (both current and from the time of manufacture): top-level drawing for termite forceps 398_95 and no design issues or discrepancies were noted.Dimensional analysis could not be performed at the region proximal to the tip that measures 1.4 mm (+0.0/-0.2) mm per 398_95 as the broken fragments were not received.However, dimensional analysis performed at the broken tip region measured 1.52 mm (ca 814) which falls in closer range to specification of 1.4 mm +0.0/-0.2 mm based on 398_95.Based on the device history record review, there is no indication that any issues with material or material properties contributed to the complaint condition.While no definitive root cause could be determined it is possible that the device encountered unintended forces during usage or handling.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: TERMITE FORCEPS 90MM
• Common Device Name: FORCEPS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7285422
• Report Number: 2939274-2018-50686
• Device Sequence Number: 1210485
• Product Code: HTD
• UDI-Device Identifier: 10886982202000
• UDI-Public: (01)10886982202000(10)T945722
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2018

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 Catalogue Number: 398.95
• Device Lot Number: T945722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2018
• Initial Date Received by Manufacturer: 01/24/2018
• Supplement Date Received by Manufacturer: 03/29/2018
• Initial Report FDA Received Date: 02/21/2018
• Supplement Report FDA Received Date: 04/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1