MAUDE Adverse Event Report: SYNTHES GMBH TFNA HELICAL BLADE PERF L85 TAN SPIRAL BLADE

Catalog Number 04.038.385S

Device Problem Migration (4003)

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

Event Date 03/18/2022

Event Type  Injury  

Manufacturer Narrative

Reporter is a j&j sales representative. The investigation could not be completed; no conclusion could be drawn, as no product was received. Investigation summary product was not returned. Based on the information available, it has been determined that no corrective and 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 a manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified. 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

Device report from depuy synthes reports an event in (b)(6) as follows: this is report 2 of 2 for (b)(4). It was reported that postoperatively to an open reduction internal fixation procedure with the tfna device for the fracture of the trochanteric femur, a cut-out occurred on (b)(6) 2022. According to the report, the initial surgery was completed successfully without any surgical delay. It was further reported that the implants will be removed on (b)(6) 2022. The total hip arthroplasty and the bipolar hip arthroplasty will not be performed. The status of the patient was unknown. No additional information was provided.

• Brand Name: TFNA HELICAL BLADE PERF L85 TAN
• Type of Device: SPIRAL BLADE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14120667
• MDR Text Key: 289358877
• Report Number: 8030965-2022-02472
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K160167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 04.038.385S
• Device Lot Number: 356P182
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 09/01/2021
• Is the Device Single Use?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 04/15/2022 Patient Sequence Number: 1