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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5 VA PROX TIB PL SMALL BEND/4H/87/LFT PLATE, FIXATION, BONE

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5 VA PROX TIB PL SMALL BEND/4H/87/LFT PLATE, FIXATION, BONE Back to Search Results
Model Number 02.127.211
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/24/2022
Event Type  malfunction  
Manufacturer Narrative
Product complaint #(b)(4). If the information is unknown, not available or does not apply, the section/field of the form is left blank. Complainant part is not expected to be returned for manufacturer review/investigation. The investigation could not be completed; no conclusion could be drawn, as no product was received. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. 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 while attempting to insert a 3. 5 va locking screw into a va locking hole, the screw would not lock into the plate. A 3. 5 cortex screw was placed in the hole and the surgery was completed successfully without any surgical delay. Additionally, it was reported that a periarticular reduction forceps was difficult to open. However, it opened freely once it was wet with irrigation. It was believed to have bioburden. The forceps remained stiff postoperatively after washing. This report is for the plate. This is report 2 of 2 for complaint (b)(4).
 
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Brand Name3.5 VA PROX TIB PL SMALL BEND/4H/87/LFT
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
WERK RARON (CH)
kanalstrasse west 30
raron 3942
SZ 3942
Manufacturer Contact
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key14171716
MDR Text Key290462912
Report Number2939274-2022-01443
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K120689
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/21/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number02.127.211
Device Catalogue Number02.127.211
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/24/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/21/2022 Patient Sequence Number: 1
Treatment
3.5 VA LCKNG SCR SLF-TPNG/SD/42; PERIARTIC-REDUCT-FORCEPS MEDIUM; UNK - SCREWS: 3.5 MM CORTEX
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