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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC LOCKING SCREW FOR IM NAIL 5/ 76/ XL25 ROD,FIXATION,INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC LOCKING SCREW FOR IM NAIL 5/ 76/ XL25 ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Model Number 04.045.076
Device Problem Migration (4003)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/30/2021
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). The device was received, the investigation is in progress, 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 removal surgery due to the locking screw backed out of the distal hole of the rfna after 2 months. The procedure was successfully completed. There were no patient consequences. Concomitant device reported: unk - nails: rafn: (part# unknown; lot# unknown; quality:1). This complaint involves one (1) device. This report is for (1) locking screw for im nail 5/ 76/ xl25. This report is 1 of 1 for (b)(4).
 
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Brand NameLOCKING SCREW FOR IM NAIL 5/ 76/ XL25
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 GRENCHEN (CH)
solothurnstrasse 186
grenchen 2540
SZ 2540
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12537337
MDR Text Key273571077
Report Number2939274-2021-05778
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K201346
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 08/30/2021
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? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number04.045.076
Device Catalogue Number04.045.076
Device Lot Number83P6613
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/22/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/06/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/13/2021
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
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