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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC RADIOLUCENT INSERTION HANDLE FRN ROD, FIXATION, INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC RADIOLUCENT INSERTION HANDLE FRN ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Model Number 03.033.001
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/29/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Complainant part is expected to be returned for manufacturer review/investigation but has yet to be 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 on (b)(6) 2021, the patient underwent for a surgery. During the surgery, while inserting the femoral nail, the driving cap component broke off and fell on the floor. The threaded portion of the driving cap that threads to the insertion handle broke at the threads. The surgeon had to mallet on the insertion handle to finish inserting the nail. No fragments were generated. The procedure successfully completed. No patient consequences. Concomitant device reported: unk - nail (part# unknown; lot# unknown; quantity: 1). Radiolucent insertion handle (part:03. 033. 001; lot: l750725; quantity: 1). This complaint involves one (1) device. This report is for (1) radiolucent insertion handle frn. This report is 1 of 2 for (b)(4).
 
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Brand NameRADIOLUCENT INSERTION HANDLE FRN
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
WERK HÄGENDORF (CH)
im bifang 6
haegendorf 4614
SZ 4614
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12532954
MDR Text Key273340189
Report Number2939274-2021-05765
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K172157
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 08/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number03.033.001
Device Catalogue Number03.033.001
Device Lot NumberL750725
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/27/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/18/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/19/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 09/27/2021 Patient Sequence Number: 1
Treatment
DRIVING CAP/THREADED.; UNK - NAILS: FEMORAL.
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