MAUDE Adverse Event Report: STRYKER GMBH T2 FE RETRO NAIL LNG D10XL360; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	2339-1036S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	03/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "a voicemail came in today from a t&e sales rep from san antonio, tx regarding the breakage of 3 retrograde femur nails within a 9-day span.This patient was revised with synthese nails.There was non-union.
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided on a supplemental report.
Event or Problem Description
As reported: "a voicemail came in today from a t&e sales rep from san antonio, tx regarding the breakage of 3 retrograde femur nails within a 9-day span.This patient was revised with synthese nails.There was non-union.
Additional Manufacturer Narrative
Correction - please refer to d1, d9/h3, h6 (method, results & conclusion codes).The reported event was confirmed.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.The item received had broken in fatigue manner after an implantation period of approx.4,5 months.The fracture pattern identified high loading.In the case presented a patient (no data given) had been treated with above nail.We received 2 undated x-rays showing the broken nail approx.At the level of the broken bone fragment.They were forwarded to a hcp for medical review.Since only 2 x-rays were available a clear decision regarding medical treatment was not possible because the period before nail breakage was completely missing.The only outcome was ¿there was some callus formation with time to consolidate, however, it did not happen.This seems to be the classical fatigue breakage of the nail, when there is no consolidation although the fracture site shows some hypertrophic/dystrophic callus formation and repair signs¿ the item broke due to axial overload which was regarded as patient related but contributed by the user.With available information a product deficiency was not verified.

• Brand Name: T2 FE RETRO NAIL LNG D10XL360
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16765725
• Report Number: 0009610622-2023-00124
• Device Sequence Number: 3061596
• Product Code: HSB
• UDI-Device Identifier: 07613327292510
• UDI-Public: 07613327292510
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K203819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2023

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 2339-1036S
• Device Catalogue Number: 23391036S
• Device Lot Number: K071C44
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2023
• Supplement Date Received by Manufacturer: 06/15/2023
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 07/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown