MAUDE Adverse Event Report: SYNTHES GMBH TFNA FENESTRATED HELICAL BLADE 105MM ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.038.405

Device Problem Migration (4003)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Device report from depuy synthes reports an event in (b)(6) as follows: it was reported that a patient underwent the revision surgery on (b)(6), 2022 due to trochanteric fixation nail-advanced (tfna) blade cut out. No further information available. This report is for one (1) unknown tfna helical blade. This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

This report is for an unknown tfna helical blade/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 expected to be returned for manufacturer review/investigation, but has yet to be received. (b)(4). Without a lot number the device history records review could not be completed. Product was not returned. 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.

• Brand Name: TFNA FENESTRATED HELICAL BLADE 105MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 13908856
• Report Number: 8030965-2022-01882
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819660021
• UDI-Public: (01)07611819660021
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K160167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 04.038.405
• Device Lot Number: 91P3824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unkown
• Patient Sex: No Answer Provided
• Patient Weight: KG
• Patient Treatment(s): UNK - LOCKING SCREW; UNK - NAILS: TFNA
• Patient Outcome(s): Required Intervention