MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC REDUCTION FORCEPS WITH POINTS BROAD-RATCHET

Catalog Number	398.41
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is unknown when device broke.Device is an instrument and is not implanted/explanted.There was no procedure involvement.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.A device history records review has been requested.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 a routine preventative maintenance procedure, the following issues were identified: five (5) depth gauge for small screws had a bent needle; one (1) reduction forceps with jaw-ratchet had a broken tip; one (1) reduction forceps with points broad-ratchet had a broken tip; one (1) reduction forceps with points broad-ratchet had a weak grip; one (1) reduction forceps with points narrow-ratchet had a broken tip; one (1) reduction forceps with points narrow-ratchet had a weak grip; one (1) application instrument for sternal zipfix had a broken tip.There was no patient or procedure involvement.This report is for a reduction forceps with points broad-ratchet.This is report 2 of 3 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.Dhr review was completed.Part number: 398.41 , synthes lot number: t986032 , release to warehouse date: 08-feb-2013 , manufacture site: tuttlingen , part expiration date: n/a , list of nonconformance¿s: n/a.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.The raw material certificate was reviewed and the used material was according to the material specification for this device.No ncrs were generated during the production of this device.Review of the device history record of tuttlingen showed that there were no issues at the time of manufacturing of this device that would contribute to the issue outlined in this complaint customer quality conducted an investigation of the returned device.Customer quality investigation: the following investigations were performed: broken: device condition: visual inspection performed at customer quality (cq) observed that one of the tips broken.No new issues were identified on other portions of the device.The complaint condition agrees with the complaint description and the complaint condition was confirmed.Dimensional analysis and document/specification review: following relevant drawings of the returned instrument was reviewed and no design issues were identified.Top level drawing for forceps.Dimensional analysis of the tip at the relevant portions measured at the thickness as 2.7 mm that falls within the specifications of 2.47 mm to 2.7 mm.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.The raw material certificate was reviewed and the used material was according to the material specification for this device.No ncrs were generated during the production of this device.Conclusion: while no definitive root cause could be determined, it is possible that any unintended forces encountered by the device could have contributed to given complaint condition.The overall complaint condition is confirmed; however, no product design issues or manufacturing discrepancies were identified during this investigation 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: REDUCTION FORCEPS WITH POINTS BROAD-RATCHET
• Common Device Name: FORCEPS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7678491
• Report Number: 2939274-2018-52814
• Device Sequence Number: 13847481
• Product Code: HTD
• UDI-Device Identifier: 10886982201386
• UDI-Public: (01)10886982201386
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 06/14/2018

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: 398.41
• Device Lot Number: T986032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2018
• Initial Date Received by Manufacturer: 06/14/2018
• Supplement Date Received by Manufacturer: 08/07/2018
• Initial Report FDA Received Date: 07/11/2018
• Supplement Report FDA Received Date: 08/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1