MAUDE Adverse Event Report: STRYKER GMBH LAG SCREW, RECON T2 RECON Ø6.5X105 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1897-6105S
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Perforation (2001)
Date of Event	10/29/2021
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.Device is not available; hospital retained.
Event or Problem Description
As reported: "(b)(6) 2021 the recon lag screw bridge the femoral head.The recon lag screw was removed on the (b)(6) 2021.The entire screw was explanted.
Event or Problem Description
As reported: "(b)(6), 2021 the recon lag screw bridge the femoral head.The recon lag screw was removed on the (b)(6) 2021.The entire screw was explanted.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned 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.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.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.If device is returned or any further information is provided, the investigation report will be reassessed.
Additional Manufacturer Narrative
Please note corrections in section d3, d4, h6 device code and clinical sign code.Please note new information in b5 executive summary.
Event or Problem Description
As reported: "(b)(6) 2021 the recon lag screw bridge the femoral head.The recon lag screw was removed on the (b)(6) 2021.The entire screw was explanted.(b)(6) 2024: during further re-assessment of this event performed by heath care professional revealed that.The word "bridge" was most probably a typo, actually meaning "breach".This means the femoral head was perforated by the lag screw.The implant is designed to prevent medial migration of the lag screws.This means there was no "migration", the perforation was caused by collapse of the fracture or avascular necrosis.The imdrf codes will be modified accordingly.

• Brand Name: LAG SCREW, RECON T2 RECON Ø6.5X105 MM
• 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: 12860615
• Report Number: 0009610622-2021-00800
• Device Sequence Number: 4265933
• Product Code: HSB
• UDI-Device Identifier: 04546540384812
• UDI-Public: (01)04546540384812(11)181116(17)231031(10)K08F35F
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K032898
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/03/2025

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 Expiration Date: 10/31/2023
• Device Model Number: 1897-6105S
• Device Catalogue Number: 18976105S
• Device Lot Number: K08F35F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2021
• Supplement Date Received by Manufacturer: 01/27/2022; 12/04/2024
• Initial Report FDA Received Date: 11/23/2021
• Supplement Report FDA Received Date: 02/24/2022; 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2018
• 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: 68 YR
• Patient Sex: Male
• Patient Race: White