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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC BENDING/CUTTING PLIERS; PLIERS,SURGICAL
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WRIGHTS LANE SYNTHES USA PRODUCTS LLC BENDING/CUTTING PLIERS; PLIERS,SURGICAL Back to Search Results
Model Number 391.962
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/19/2020
Event Type  malfunction  
Manufacturer Narrative
Additional narrative: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is company representative.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; 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 during an unknown procedure on (b)(6) 2020, a part of the bending/cutting pliers chipped off while cutting the 2.7 locking compression plate (lcp) adaptation plate.The cutting pliers successfully cut the plate but chipped in the process.The piece was recovered on the back table.The procedure was successfully completed without a surgical delay.There was no patient consequence reported.Concomitant device reported: unknown 2.7 lcp adaptation plate (part # unknown, lot # unknown, quantity 1) this complaint involves one (1) device.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: the device has been 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.
 
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, h4, h6- the bending/cutting pliers (p/n:391.962, lot #: t991566) was returned and received at us cq.Upon visual inspection, the carbide insert was missing on the cutting slot of the device and the device was observed to be functioning loose.There were scratches observed on the device but has no impact on the functionality of the device.No other issues were observed with the returned components of the device.The complaint condition is confirmed for the bending/cutting pliers (p/n:391.962, lot #: t991566).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 history lot part number: 391.962, lot number: t991566, manufacturing site: tuttlingen, release to warehouse date: 07-jun-2013.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.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.
 
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Brand Name
BENDING/CUTTING PLIERS
Type of Device
PLIERS,SURGICAL
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
MDR Report Key10106122
MDR Text Key193113091
Report Number2939274-2020-02623
Device Sequence Number1
Product Code HTC
UDI-Device Identifier10886982198525
UDI-Public(01)10886982198525
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 05/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/01/2020
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number391.962
Device Catalogue Number391.962
Device Lot NumberT991566
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/05/2020
Date Manufacturer Received06/18/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
UNK - PLATES; UNK - PLATES
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