MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DETACHABLE FLEX SHAFT; SCREW, FIXATION, BONE

Model Number	2107-2200
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Broken item during procedure.No bits broken off or left inside of patient.Delay to surgery ¿ minimal whilst opening another set.No harm came to patient.
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Broken item during procedure.No bits broken off or left inside of patient.Delay to surgery ¿ minimal whilst opening another set.No harm came to patient.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a trident driver shaft was reported.The event was confirmed via evaluation of the returned device.Method & results: product evaluation and results: visual inspection of the returned device indicated that the outer layer of coils of the flexible shaft have unwound and the coiled wires of the shaft near the tip have fractured.This indicates that the flexible drill shaft fractured in overload.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there has been no other similar events for the lot referenced.Conclusions: it was reported that the flexible drill shaft fractured during surgery.Visual inspection of the returned device indicated that the outer layer of coils of the flexible shaft have unwound and the coiled wires of the shaft near the tip have fractured.This indicates that the flexible drill shaft fractured in overload.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: DETACHABLE FLEX SHAFT
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15648767
• Report Number: 0002249697-2022-01531
• Device Sequence Number: 2356561
• Product Code: HWC
• UDI-Device Identifier: 07613327212327
• UDI-Public: 07613327212327
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K161569
• 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): 01/11/2023

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: 2107-2200
• Device Catalogue Number: 2107-2200
• Device Lot Number: BEHAY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/29/2022
• Supplement Date Received by Manufacturer: 12/17/2022
• Initial Report FDA Received Date: 10/21/2022
• Supplement Report FDA Received Date: 01/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2019
• 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: Other
• Patient Sex: Unknown