MAUDE Adverse Event Report: STRYKER GMBH LAG SCREW, TI GAMMA3 Ø10.5X100MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	30600100S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Perforation (2001)
Date of Event	03/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "i'm in peterborough hospital, they have a gamma nail where the lag screw has migrated into the pelvis.The extraction is today.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "i'm in peterborough hospital, they have a gamma nail where the lag screw has migrated into the pelvis.The extraction is today.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the visible marks on the lag screw confirm the migration.The device inspection revealed the following: the lag screw, the nail including the corresponding set screw and a locking screw were returned for evaluation.The visual inspection of the set screw has shown there is a strong deformation at one side of the set screw while the top surface has no visible mark that could be traced back to a contact with the bottom of the lag screw groove during tightening.The kind of the damage indicates that the set screw was most like tightened at the edge of the groove and not at the bottom as required.All grooves of the returned lag screw were inspected under the microscope and the typical imprint, which is caused during the tightening of the set screw in the groove is missing, there is no indication that the set screw was tightened in the groove after the insertion.There are thread shaped marks at the end of the lag screw visible.These marks are an indication for a contact between the set screw and the surface of the lag screw while the lag screw did migrate.Based on these marks it is possible to confirm the migration of the lag screw.A functional test with the received nail, lag screw and an intact sample set screw was performed.The set screw could be inserted and positioned in the grooves without any issues, after slight tightening of the set screw a clearly visible imprint was present in the groove of the lag screw.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.Based on investigation, the root cause was attributed to a user related issue.The event was most likely caused by an improper positioning of the set screw.The visible damages indicate that the screw set was initially tightened on the edge instead of the bottom of the groove.After the set screw was then unscrewed by a quarter of a turn, as described in the surgical technique, it was no longer positioned in the lag screw groove as intended.If more information is provided, the case will be reassessed.
Additional Manufacturer Narrative
H6 imdrf results code has been updated.
Event or Problem Description
As reported: "i'm in (b)(6) hospital, they have a gamma nail where the lag screw has migrated into the pelvis.The extraction is today.".

• Brand Name: LAG SCREW, TI GAMMA3 Ø10.5X100MM
• 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: 19086039
• Report Number: 0009610622-2024-00150
• Device Sequence Number: 15366587
• Product Code: HSB
• UDI-Device Identifier: 04546540374943
• UDI-Public: 04546540374943
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K200869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/15/2024

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 30600100S
• Device Lot Number: K1707A8
• 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: 03/15/2024
• Supplement Date Received by Manufacturer: 05/29/2024; 09/19/2024
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 06/26/2024; 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2023
• 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