MAUDE Adverse Event Report: STRYKER TRAUMA KIEL HAND REAMER BIXCUT Ø6X450 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	0227-0060
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	08/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of the investigation any additional information will be communicated in a supplemental report.
Event or Problem Description
It was reported that during a t2 tibial nail case the smallest non-cannulated rigid bixcut reamer shaft snapped and the distal end of the reamer shaft got stuck in the tibial canal.After several attempts to remove the broken reamer without making another incision, the surgeon decided to make an incision over the fracture site.The broken reamer was pushed back up the canal using a ronger.There was a surgical delay of 150 minutes as a result of the event.
Event or Problem Description
It was reported that during a t2 tibial nail case the smallest non-cannulated rigid bixcut reamer shaft snapped and the distal end of the reamer shaft got stuck in the tibial canal.After several attempts to remove the broken reamer without making another incision, the surgeon decided to make an incision over the fracture site.The broken reamer was pushed back up the canal using a ronger.There was a surgical delay of 150 minutes as a result of the event.
Additional Manufacturer Narrative
D9 / h3 updated to indicate device was not returned.The reported event could not be confirmed, since the affected device was not returned for evaluation and no other evidence was provided.A device inspection was not possible since the affected device was not returned for evaluation.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 information as well as the affected device must be available in order to determine the exact root cause of the issue.However, through the additional communication it was communicated that the patient had hard bone.So application of excessive force in order to appreciate through the hard bone may be one of the probable causes.If any additional information is provided, the investigation will be reassessed.

• Brand Name: HAND REAMER BIXCUT Ø6X450 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: kristen canter ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12377610
• Report Number: 0009610622-2021-00671
• Device Sequence Number: 11057894
• Product Code: LXH
• UDI-Device Identifier: 07613154556489
• UDI-Public: 07613154556489
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2021

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 Model Number: 0227-0060
• Device Catalogue Number: 02270060
• Device Lot Number: KU75708
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/03/2021
• Supplement Date Received by Manufacturer: 10/27/2021
• Initial Report FDA Received Date: 08/27/2021
• Supplement Report FDA Received Date: 11/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2013
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 21 YR
• Patient Sex: Male