MAUDE Adverse Event Report: STRYKER GMBH LAG SCREW GAMMA4 Ø10.5X90MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	81600090S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); Implant Pain (4561)
Date of Event	03/31/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.H3 other text : device disposition is unknown.
Event or Problem Description
It was reported: "a patient presented with increasing pain at the hip consistent with non-union on x-rays the removal of painful hardware (gamma-4) yesterday, non-union bone repair and ultimately fixation with a non-stryker nail".Additional information indicates nail breakage is present.
Additional Manufacturer Narrative
The reported non-union could be confirmed based on the received information.A device inspection was not possible since the affected device was not returned.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.The complaint was forwarded to medical affairs for review with the following results: ¿there is limited information here.The x-rays provided are after the breakage of the nail.Interesting case.Clearly there was a non-union or delayed union at 6 months.In a united bone, the nail would not break anymore.There are some interesting things to be seen on the provide x-rays.Distally, the screw seems to be quite short, and the question arises whether it ever was long enough to penetrate the second cortex properly.It is quite clear the screw backed out and that occurred quite a while ago since there is a bump of callus formation around the head of the screw.The backing out of the screw can be explained if the screw indeed was too short and did not have sufficient hold in the second cortex.The backing out led to movement in the nail since it lost its distal stability.Proximally, the current x-ray suggest this was a sub trochanteric fracture, which needs more stability in the implant than a per trochanteric one with intrinsic stability.If the distal stability in the implant is lost, movement of the nail will have influence on the fracture area and thus the lag screw-nail interface.The lag screw is not entirely in the ideal position, which may or may not have had additional influence on the movement in the fracture site, leading to a non-union and subsequent nail breakage.Based on the provided information, the root cause of the reported event is multi-factorial.The location of the fracture and the technical aspects of the surgical procedure continued to the event.Furthermore, patient activity levels post-op may have also contributed to an inadequate load distribution, and therefore the breakage of the implant.If the device is returned or any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported: "a patient presented with increasing pain at the hip consistent with non-union on x-rays the removal of painful hardware (gamma-4) yesterday, non-union bone repair and ultimately fixation with a non-stryker nail".Additional information indicates nail breakage is present.

• Brand Name: LAG SCREW GAMMA4 Ø10.5X90MM
• 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: 19182191
• Report Number: 0009610622-2024-00169
• Device Sequence Number: 7147956
• Product Code: HSB
• UDI-Device Identifier: 07613327510928
• UDI-Public: 07613327510928
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K213328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2024

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 81600090S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/03/2024
• Supplement Date Received by Manufacturer: 06/06/2024
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 06/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 61 YR
• Patient Sex: Female
• Patient Weight: 128 KG