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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR LOCKING SCREWS TO 100MM FOR IM NAILS GAUGE,DEPTH

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR LOCKING SCREWS TO 100MM FOR IM NAILS GAUGE,DEPTH Back to Search Results
Model Number 03.010.428
Device Problem Material Twisted/Bent (2981)
Patient Problem No Patient Involvement (2645)
Event Date 10/25/2020
Event Type  malfunction  
Manufacturer Narrative
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 a tibial nail insertion on (b)(6) 2020, the depth gauge for locking screws has lost its integrity. It was mentioned that the reported device was bent so many times that it no longer reads the correct length for screw. The procedure was successfully completed with the use of another depth gauge. There was a 10 minutes surgical delay. Patient status is unknown. Concomitant device reported: unknown locking screw (part # unknown, lot # unknown, quantity unknown) unknown tibial nail (part # unknown, lot # unknown, quantity 1). This complaint involves one (1) device. This report is for (1) advanced appl inner shaft. This is report 1 of 1 for (b)(4).
 
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Brand NameDEPTH GAUGE FOR LOCKING SCREWS TO 100MM FOR IM NAILS
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 SELZACH
bohackerweg 5
selzach 2545
SZ 2545
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key10864438
MDR Text Key217452549
Report Number2939274-2020-05221
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
Type of Report Initial,Followup
Report Date 10/25/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number03.010.428
Device Catalogue Number03.010.428
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 Received11/22/2020
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? No
Type of Device Usage Unkown

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