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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HANDLE F/PERCUTANEOUS THREADED DRILL GUIDES GAUGE,DEPTH

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC HANDLE F/PERCUTANEOUS THREADED DRILL GUIDES GAUGE,DEPTH Back to Search Results
Model Number 03.113.014
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Patient Involvement (2645)
Event Date 09/05/2020
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. 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 a tibial plateau case on (b)(6) 2020, the unknown aiming arm and the 1. 6 mm threaded wire guide was fused together with the handle for drill sleeves and could not be able to get those pieces apart which each other. The issue caused a small delay to the procedure. Another device was used on the case. Patient status and surgical outcomes was successful. This complaint involves three (3) devices. This report is for (1) handle f/percutaneous threaded drill guides. This is report 2 of 3 for (b)(4).
 
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Brand NameHANDLE F/PERCUTANEOUS THREADED DRILL GUIDES
Type of DeviceGAUGE,DEPTH
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 Key10600030
MDR Text Key208974233
Report Number2939274-2020-04371
Device Sequence Number1
Product Code HTJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/05/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number03.113.014
Device Catalogue Number03.113.014
Device Lot Number8581991
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/05/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/05/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/09/2013
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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