MAUDE Adverse Event Report: SYNTHES GMBH 12MM/125 DEG TI CANN TFNA 300MM/LEFT - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 04.037.221S

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

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

Event Description

Device report from synthes (b)(6) reports an event as follows: it was reported that on (b)(6), 2021, the patient underwent surgery for reverse oblique type fractures of proximal femur.Since it was an unstable fracture, the patient had been left with no load after the surgery, but internal inversion pseudoarthrosis occurred.On (b)(6), 2022, the revision surgery was performed.In the revision surgery, all the implants used in the initial surgery were removed and a bipolar hip arthroplasty (bha) was performed with the non-synthes products.The revision surgery was completed successfully with no problems.Regarding the cause of nonunion, the surgeon commented that it was caused by insufficient fixation of the fracture site.This report is for a trochanteric fixation nail advanced (tfna) nail.This is report 3 of 6 for (b)(4).

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.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.

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d4 h4 device history: part #: 04.037.221s, lot #: 9962978, manufacturing site: werk selzach , supplier: (b)(4), release to warehouse date: 22 feb 2016, expiration date: 01 feb 2026, a manufacturing record evaluation was performed for the finished device lot number, 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.

• Brand Name: 12MM/125 DEG TI CANN TFNA 300MM/LEFT - STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13551877
• MDR Text Key: 286437691
• Report Number: 8030965-2022-00961
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819651036
• UDI-Public: (01)07611819651036
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.037.221S
• Device Lot Number: 9962978
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2022
• Initial Date FDA Received: 02/17/2022
• Supplement Dates Manufacturer Received: 03/10/2022
• Supplement Dates FDA Received: 04/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: FEM-NECKSCR PERF L85 TAN.; LOCKSCR Ø5 L36 F/NAILS TAN.; LOCKSCR Ø5 L38 F/NAILS TAN LIGHT GREEN.; LOCKSCR Ø5 L38 F/NAILS TAN LIGHT GREEN.; TRAUMACEM V+ CEMENT KIT 10 ML.
• Patient Outcome(s): Required Intervention
• Patient Age: 90 YR
• Patient Sex: Female