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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - NAILS: TFNA ROD, FIXATION, INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - NAILS: TFNA ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number UNK - NAILS: TFNA
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Event Description
It was reported that on an unknown date, the sales rep was notified that the surgeon will be removing a tfna construct and convert to a total hip arthroplasty. According to the report, the surgeon attempted to remove this nail on (b)(6) 2022, however was unable to get the distal interlocking screw out. Subsequently he decided to return at a future date. It was reported that the tfna nail construct was successfully removed on (b)(6) 2022. The status of the patient post-removal was unknown. No additional information was provided. This report is for one (1) unk - nails: tfna device. This complaint involves one(1) device.
 
Manufacturer Narrative
Additional narrative: 510k: this report is for an unknown device/unknown lot. Part and lot number are unknown. Without the specific part number; the udi number and 510-k number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. (b)(4). Investigation summary: the photo was returned to depuy synthes for evaluation. The depuy synthes team conducted a visual inspection of the returned device. Visual analysis of the photo revealed that the unk - nails: tfna had no visible defects or issues. As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed. As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications. The overall complaint was not confirmed for the unk - nails: tfna. There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined. Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed. Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities. 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 NameUNK - NAILS: TFNA
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key14253157
MDR Text Key290444361
Report Number2939274-2022-01565
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK - NAILS: TFNA
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/04/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 04/29/2022 Patient Sequence Number: 1
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