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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC NAIL EXTRACTOR ROD, FIXATION, INTRAMEDULLARY

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WRIGHTS LANE : SYNTHES USA PRODUCTS LLC NAIL EXTRACTOR ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 03.037.032
Device Problems Device Slipped (1584); Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/27/2021
Event Type  malfunction  
Event Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent for a surgery. During the surgery, the extraction piece does not screw into the nail, it remains loose for this reason it cannot be used for extraction. It was unknown if the surgery completed successfully. The patient outcome is unknown. Concomitant device reported: unk - nails: (part# unknown; lot# unknown; quantity: unknown). This complaint involves (1) device. This report is for (1) nail extractor. This report is 1 of 1 for (b)(4).
 
Manufacturer Narrative
Product complaint # (b)(4). Complainant part is expected to be returned for manufacturer review/ investigation but has yet to be received. Reporter is a j&j representative. 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.
 
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Brand NameNAIL EXTRACTOR
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 Key13085390
MDR Text Key283612729
Report Number8030965-2021-10464
Device Sequence Number1
Product Code HSB
UDI-Device Identifier07611819642584
UDI-Public(01)07611819642584
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K131548
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.037.032
Device Lot Number9286658
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/16/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/16/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/11/2014
Is the Device Single Use? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 12/24/2021 Patient Sequence Number: 1
Treatment
UNK - NAILS
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