MAUDE Adverse Event Report: SYNTHES GMBH TFNA END CAP EXTENS. 0 TAN; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 04.038.000S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 04/01/2022

Event Type  Injury  

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.The initial reporter is a j&j sales representative.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.

Event Description

Device report from synthes reports an event in japan as follows: this pc is related to (b)(4) which reports that the infection was suspected during the removal surgery.This pc reports that the secondary fracture occurred due to fall after the surgery.It was reported that on (b)(6) 2021, the patient underwent the open reduction internal fixation with the tfna for the trochanteric fracture of the femur.In (b)(6) 2022, the patient fell off, and the fracture occurred.The surgeon decided to remain implants in place and treated conservatively.This report is for one (1) tfna end cap extens.0 tan.This is report 3 of 4 for complaint (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Part #: 04.038.000s, lot #: 261p494, manufacturing site: jabil bettlach, release to warehouse date: 21, july 2021, expiry date: 01, july 2031.A manufacturing record evaluation was performed for the finished device lot and no non-conformance was 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.

• Brand Name: TFNA END CAP EXTENS. 0 TAN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach CO ; SZ
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15840987
• MDR Text Key: 304090664
• Report Number: 8030965-2022-10129
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819648708
• UDI-Public: (01)07611819648708
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.038.000S
• Device Lot Number: 261P494
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: LOCKSCR Ø5 L38 F/NAILS TAN LIGHT GREEN; TFNA FEM NAIL Ø10 LE 125° L235 TIMO15; TFNA HELICAL BLADE PERF L100 TAN
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male