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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC COLLAR POSITIONER FOR DUAL-OPENING IMPL F/6.0MM RODS PLIERS,SURGICAL

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC COLLAR POSITIONER FOR DUAL-OPENING IMPL F/6.0MM RODS PLIERS,SURGICAL Back to Search Results
Catalog Number 388.151
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/29/2019
Event Type  Malfunction  
Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. 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 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 a piece of collar positioner "sleeve" broke off during impaction. Instrument will be returned. Unknown if fragments were generated, procedure successfully completed, or if surgery delayed due to the reported event. Concomitant device reported: unknown collar impactor (part#unknown, lot#unknown, quantity#1). This complaint involves (1) device. This report is 1 of 1 for (b)(4).

 
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Brand NameCOLLAR POSITIONER FOR DUAL-OPENING IMPL F/6.0MM RODS
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 HAEGENDORF GMBH-CN
im bifang 6
haegendorf 4614
SZ 4614
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key9120466
MDR Text Key160127117
Report Number2939274-2019-60887
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,Followup,Followup
Report Date 08/30/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/25/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number388.151
Device LOT Number1159723
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/10/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/30/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/30/2003
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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