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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 Clinical Signs, Symptoms or Conditions (4582)
Event Type  Malfunction  
Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received. Reporter is jnj 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

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021 in the inspection time it was discovered that the pointed tooth of plier has chipped off. There was no surgery and patient involvement reported. This complaint involves one (1) device. This report is for (1) unk - plates. This is report 1 of 1 (b)(4).

 
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Brand NameBENDING/CUTTING PLIERS
Type of DevicePLIERS,SURGICAL
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
SYNTHES TUTTLINGEN
unter hasslen 5
tuttlingen 78532
GM 78532
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key11315777
MDR Text Key238642412
Report Number2939274-2021-00798
Device Sequence Number1
Product Code HTC
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 01/22/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/11/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number391.962
Device Catalogue Number391.962
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/22/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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