MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DETACHABLE FLEX SHAFT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	2107-2200
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
It has been reported "breakage probably due to metal fatigue.".
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: 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.Material analysis: review of the device with a materials analysis engineer indicated that the flexible drill shaft fractured in overload.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.-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 1 other similar event 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.Review of the device with a materials analysis engineer indicated that the flexible drill shaft fractured in overload.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.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.
Event or Problem Description
It has been reported "breakage probably due to metal fatigue.

• Brand Name: DETACHABLE FLEX SHAFT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 12715758
• Report Number: 0002249697-2021-01800
• Device Sequence Number: 4239516
• Product Code: LXH
• UDI-Device Identifier: 07613327212327
• UDI-Public: 07613327212327
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2022

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: 2107-2200
• Device Catalogue Number: 2107-2200
• Device Lot Number: BSKCA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2021
• Supplement Date Received by Manufacturer: 10/25/2022
• Initial Report FDA Received Date: 10/28/2021
• Supplement Report FDA Received Date: 11/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/1999
• 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: Female