MAUDE Adverse Event Report: STRYKER GMBH LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 Ø11X380MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	34251380S
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	10/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the implantation took place on (b)(6) 2023 without problems.In (b)(6) 2023, a nail fracture occurred during rehab.
Additional Manufacturer Narrative
The information in this report was provided by stryker legal affairs department.No additional information is available currently due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.Upon completion of the investigation, additional information will be provided in a supplemental report.
Additional Manufacturer Narrative
Correction - please refer to d9 - the product was not returned for evaluation.The reported event could not be confirmed since the device was not returned for evaluation and no other evidence was provided.A device inspection was not possible since the affected device was not returned and no other evidence was provided for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Reasons for potential nail breakage are clearly listed.No indications of material, manufacturing or design related problems were found during the investigation.In the case presented a female patient (no data given) had been treated with above implant on allegedly (b)(6) 2023.Allegedly on (b)(6) 2023, revision was required due to nail breakage during rehab.We received 3 x-ray copies; 1 dated on (b)(6) 2024: showing the broken trochanter in a-p-view, another copy dated on (b)(6) 2023 showing the treatment with a gamma nail in a-p-view, presenting the distal locking configuration.A 3rd copy, dated on (b)(6) 2023, in a-p-view, showing the proximal locking configuration.The date of event (nail breakage) was cited being october 15, 2023, thus, available x-rays are immediately post-op views.Further information was not available.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.With available information a root cause could not be determined.With available information a product deficiency could not be verified.If essential information will become available we reserve the right to re-open the case and to re-assess potential root causes.
Event or Problem Description
It was reported that the implantation took place on (b)(6) 2023 without problems.In (b)(6) 2023, a nail fracture occurred during rehab.
Event or Problem Description
It was reported that the implantation took place on (b)(6) 2023 without problems.In (b)(6) 2023, a nail fracture occurred during rehab.
Additional Manufacturer Narrative
Please note the corrections to d9, h6 clinical signs, method, results and conclusion codes.The reported event could be confirmed, since the returned nail is broken as described in the event description.The device inspections revealed the following: the broken nail was returned for evaluation.The breakage occurred at the lag screw hole.The complete proximal fragment of the nail was not returned.Therefore it was not possible to verify the catalog- and lot number of the nail, because the laser markings are on this part of the nail.Together with the nail two locking screw were returned, one of the screws was also broken and the other screw was found to be deformed and cracked.These devices could be identified based on the laser markings below the screw head.During the microscopic inspection of the nail fracture face the typical characteristics of a fatigue fracture could be identified on both fracture faces.There is a fatigue zone with a smooth surface and progression lines which ends in a rougher instantaneous zone, where the nail finally broke apart.There are strong impression marks from the lag screw, which was not returned for evaluation, in the lag screw hole visible.These marks are consistent with high load transfer from the lag screw during continuous weight-bearing.At both distal locking holes were impression marks on top of the holes visible.These marks can be traced back to the pressure exerted by the nail on the locking screws.The inspection of the thread of the broken screw has shown that the thread flanks are flattened next to the fracture face.This damage can be traced back to a high load transfer from the nail to the locking screw.During the microscopic inspection of the broken locking screw fracture face the typical characteristics of a fatigue fracture could be identified on both fracture faces.There is a fatigue zone with a smooth surface and progression lines which ends in a rougher instantaneous zone, where the screw finally broke apart.A microscopic inspection was also performed at the second locking screw that was returned and did at the first glance seem to be intact.The inspection has shown that also at this screw the thread flanks are flattened, which can be traced back to a high load transfer from the nail to the locking screw.Next to the damage is a crack visible.This crack is also a sign of fatigue, and it would only have been a matter of time before this screw broke as well.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Reasons for potential nail breakage are clearly listed.No indications of material, manufacturing or design related problems were found during the investigation.The available information was forwarded to medical affairs for review with following feedback: "a highly unstable comminuted fracture was managed using a long nail.Assessment is limited due to the availability of only single directional view x-rays; while the reduction appears satisfactory in this perspective, stability cannot be confirmed in other directions.The presence of fracture gaps suggests ongoing instability.There is no evidence of three-point fixation, and the isthmus offers no support.Significant movement at the lag screw interface is likely responsible for implant failure.The absence of callus formation during revision surgery for the broken nail indicates delayed healing, which is logically attributed to the persistent instability." conclusion: no product related issue could be detected during the performed investigation of the returned devices.The construct ultimately failed to withstand the applied force, resulting in material overload and fatigue failure of the devices.Given the limited information available - such as the reliance on single-view x-rays and the absence of the proximal end of the nail and the lag screw - the precise root cause of the reported event cannot be determined, as this is often muti-factorial: in this case the location of the fracture and the technical aspects of the surgical procedure did contributed to the event.But furthermore, patient condition and activity levels post-op may also have contributed to an inadequate load distribution, and therefore the breakage of the implants.If more information is provided, the case will be reassessed.

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 Ø11X380MM X 125°
• 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: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20153763
• Report Number: 0009610622-2024-00828
• Device Sequence Number: 8369472
• Product Code: HSB
• UDI-Device Identifier: 07613252273844
• UDI-Public: (01)07613252273844(17)280131(10)K1029A9
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K200869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/24/2026

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 Catalogue Number: 34251380S
• Device Lot Number: K1029A9
• 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: 08/07/2024
• Supplement Date Received by Manufacturer: 10/31/2024; 02/12/2026
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 11/24/2024; 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2023
• 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