MAUDE Adverse Event Report: STRYKER TRAUMA KIEL IM REAMER SHAFT, AO FITTING, DOVETAIL BIXCUT Ø8,0X448 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	0226-3000
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that : "breakage of the reamer stryker adaptor in intraoperative with the reamer head remaining in the patient's bone." action taken : remove the alesor introduced into the femur.Customer reported that: "incidental description: during a femur nailing procedure, the motor adapter of the stryker reamer broke while the surgeon was using it on the patient." clinical consequences found: activity performed with a loss of time and/or quality conservative measures and actions taken: remove the reamer inserted in the femur + the guide pin which were no longer attached to the motor adapter.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the provided im reamer shaft of the bixcut system shows extensive signs of usage and rework which wiped the details used for device identification.The reamer shaft is broken at the last windings near the adapter.Most likely the dovetail pegs of the used bixcut head got broken.The bixcut head was not provided.The breakage surfaces show the typically rough and cliffy structure of a ductile overload fracture.Also, the outer spiral is not un-winded the reamer shaft broke during operating in a clockwise direction due to torsional overload.The device history record could not be reviewed because the affected device returned was wiped from the area where the lot number is mentioned and only half can be seen, and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.Based on the investigation, the root cause was attributed to a user-related issue.The failure was caused by torsional overloading.Most likely the reamer head got stuck into a hard bone and due to operating the jammed reamer shaft the spiral material got overloaded and broke.If any further information is provided, the complaint report will be updated.
Event or Problem Description
It was reported that : "breakage of the reamer stryker adaptor in intraoperative with the reamer head remaining in the patient's bone." action taken : remove the alesor introduced into the femur.Customer reported that: "incidental description: during a femur nailing procedure, the motor adapter of the stryker reamer broke while the surgeon was using it on the patient." clinical consequences found: activity performed with a loss of time and/or quality conservative measures and actions taken: remove the reamer inserted in the femur + the guide pin which were no longer attached to the motor adapter.

• Brand Name: IM REAMER SHAFT, AO FITTING, DOVETAIL BIXCUT Ø8,0X448 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• 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: 15569224
• Report Number: 0009610622-2022-00458
• Device Sequence Number: 5861888
• Product Code: LXH
• UDI-Device Identifier: 04546540145550
• UDI-Public: 04546540145550
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0226-3000
• Device Catalogue Number: 02263000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/14/2022
• Supplement Date Received by Manufacturer: 11/15/2022
• Initial Report FDA Received Date: 10/10/2022
• Supplement Report FDA Received Date: 12/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown