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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 8 TI MULTILOC PROX HUM NL/LFT/CANN/160-S ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 8 TI MULTILOC PROX HUM NL/LFT/CANN/160-S ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 04.016.035S
Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bone Fracture(s) (1870); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/03/2022
Event Type  Injury  
Event Description
Device report from synthes reports an event in the usa as follows: it was reported on (b)(6) 2022, that the graphic case for the multiloc nail was bent prior to opening before the surgery. A short multiloc nail was inserted during the surgery. A fracture was created in the shaft of the nail during insertion,. The nail was removed, and a new long nail was used to span the fracture created by the nail. The surgery was successfully completed and there was a patient involvement. This complaint involves one (1) devices 8 ti multiloc prox hum nl/lft/cann/160-s. This is report 1 of 1 for complaint (b)(4).
 
Manufacturer Narrative
Product complaint # (b)(4). Complainant part is not expected to be returned for manufacturer review/investigation. A review of the device history record has been requested. 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.
 
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Brand Name8 TI MULTILOC PROX HUM NL/LFT/CANN/160-S
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
WERK MEZZOVICO (CH)
via cavazz 5
mezzovico 6805
SZ 6805
Manufacturer Contact
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key13966457
MDR Text Key288308826
Report Number2939274-2022-01136
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K103002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number04.016.035S
Device Catalogue Number04.016.035S
Device Lot Number87P8822
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/28/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/29/2021
Is the Device Single Use? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 03/31/2022 Patient Sequence Number: 1
Treatment
GC FOR MULTILOC PROX HUM NL INST SET; UNK - INSERTION INSTRUMENTS: TRAUMA
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