MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø11X360MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 3525-1360S

Device Problems Break (1069); Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 09/01/2021

Event Type  Injury  

Manufacturer Narrative

Upon completion of the investigation any additional information will be communicated in a supplemental report.Device disposition is unknown.

Event Description

It was reported that a gamma nail broke at the lag screw hole 4 months post-op.Revision surgery was scheduled for (b)(6) 2021.More information about the revision has not been provided.

Event Description

It was reported that a gamma nail broke at the lag screw hole 4 months post-op.Revision surgery was scheduled for (b)(6) 2021.More information about the revision has not been provided.

Manufacturer Narrative

Please refer correction to sections d1, d2a and d2b, d4 (catalog and lot numbers) and h6 (method, results and conclusion codes).The reported event could not be confirmed since the device was not returned for evaluation and no other evidence was provided.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.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.No indications of material, manufacturing or design related problems were found during the investigation.If more information is provided, the case will be reassessed.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Manufacturer Narrative

Please note corrections to sections d9/h3; the device was returned, and h6 (device, method, results and conclusion codes).The reported event could be confirmed, since the nail is broken apart as complained.The device inspection revealed the following: the visual inspection has shown that the nail is broken apart at the lag screw bore.There are strong impression marks from the lag screw in the bore visible, which indicates that the nail was exposed to high loads.The typical characteristics of a fatigue fracture can be identified at the fracture face.The origin of the crack is visible and there is a fatigue zone with a smooth surface and progression lines over almost the whole surface of the fracture.At the fracture initiation zone is a deformation at the bore and stress marks from reaming visible.Afterwards it is not possible to determine if the deformation was caused during implantation by an excessive contact with the reamer or in situ by rubbing on the lag screw after the breakage.The relevant dimensions were verified during the investigation and no deviation from the specification could be detected.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.No indications of material, manufacturing or design related problems were found during the investigation.The nail was returned for evaluation and no product related issue could be detected.There was no additional information about the event provided, no x-rays and no information about the patient was made available.Therefore the root cause of the breakage cannot be defined.The evaluation of the received nail has shown that fatigue did lead to the breakage of the device.In this relation following statement from the instructions for use (non-active implant) can be pointed out: "these devices can break when subjected to the increased loading associated with delayed unions and/or non-unions.Internal fixation devices are load sharing devices which are intended to hold fractured bone surfaces in apposition to facilitate healing.If healing is delayed or does not occur, the appliance may eventually break due to metal fatigue.Loads on the device produced by load bearing and the patient¿s activity level will dictate the longevity of the device." if more information is provided, the case will be reassessed.

Event Description

It was reported that a gamma nail broke at the lag screw hole 4 months post-op.Revision surgery was scheduled for (b)(6), 2021.More information about the revision has not been provided.Update: during the inspection one of the returned locking screws was found broken due to fatigue.

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø11X360MM X 125°
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• 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: 12509610
• MDR Text Key: 272575617
• Report Number: 0009610622-2021-00700
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07613252274285
• UDI-Public: 07613252274285
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K200869
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/09/2022

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
• Device Operator: Lay User/Patient
• Device Model Number: 3525-1360S
• Device Catalogue Number: 35251360S
• Device Lot Number: K0281E5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/01/2021
• Initial Date FDA Received: 09/21/2021
• Supplement Dates Manufacturer Received: 11/24/2021; 05/16/2022
• Supplement Dates FDA Received: 12/21/2021; 06/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention