MAUDE Adverse Event Report: STRYKER GMBH REAMER SHAFT, MOD.TRINKLE BIXCUT Ø8X885 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	02278885S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
As reported: "drill fracture when drilling distal ap locking screw of suprapatellar nail.The drill came out short and it shows drill bit intraosseous posterior to the nail.Procedure completed successfully as there were 2 ml locking screws used.No further delay.No additional intervention required.The plan was to use 3 distal locking screws to optimise stability in the poor distal tibia bone quality.Rigidity of fixation resulted to be marginally inferior.The fragment is intraosseous posterior to the nail, not feasible to remove.Distal end is in the tibia.".
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidence were provided.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.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 the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "drill fracture when drilling distal ap locking screw of suprapatellar nail.The drill came out short and it shows drill bit intraosseous posterior to the nail.Procedure completed successfully as there were 2 ml locking screws used.No further delay.No additional intervention required.The plan was to use 3 distal locking screws to optimise stability in the poor distal tibia bone quality.Rigidity of fixation resulted to be marginally inferior.The fragment is intraosseous posterior to the nail, not feasible to remove.Distal end is in the tibia.".

• Brand Name: REAMER SHAFT, MOD.TRINKLE BIXCUT Ø8X885 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22100886
• Report Number: 0008031020-2025-00934
• Device Sequence Number: 8526675
• Product Code: LXH
• UDI-Device Identifier: 04546540722324
• UDI-Public: (01)04546540722324(17)291231(10)K0F9FF2
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2025

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: Health Professional
• Device Catalogue Number: 02278885S
• Device Lot Number: K0F9FF2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/02/2025
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/17/2025
• 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