MAUDE Adverse Event Report: STRYKER GMBH RC LAG SCREW GAMMA4 Ø10.5X85MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	81660085S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	01/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "gamma4 u-lag screw penetration was occurred".
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.

• Brand Name: RC LAG SCREW GAMMA4 Ø10.5X85MM
• 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: 21417489
• Report Number: 0008031020-2025-00337
• Device Sequence Number: 7775076
• Product Code: HSB
• UDI-Device Identifier: 07613327591798
• UDI-Public: 07613327591798
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K230512
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/19/2025

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: 81660085S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Sex: Unknown