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	08/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Surgeon was using drill to drill holes for screws in patients acetabulum.The flexible drill broke.Surgeon washed out the hole to remove any potential small fragments left in hole.Primary tha.
Additional Manufacturer Narrative
An event regarding damage involving a trident driver shaft was reported.The event was confirmed through visual evaluation of the provided photograph.Method & results: device evaluation and results: no product was returned for evaluation however photographs were provided for review.The photograph show different instruments on a table.The driver shaft is broken/fractured.Clinician review: no medical records were received for review with a clinical consultant.Device history review: could not be performed as lot code information was not provided.Complaint history review: could not be performed as lot code information was not provided.Conclusion: the event was conformed through evaluation of the provided photographs.The photograph show different instruments on a table.The driver shaft is broken/fractured.The exact cause of the event could not be confirmed as insufficient information was provided.Further information such as return of the device are required to complete the investigation and determine a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Surgeon was using drill to drill holes for screws in patients acetabulum.The flexible drill broke.Surgeon washed out the hole to remove any potential small fragments left in hole.Primary tha.

• 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15407856
• Report Number: 0002249697-2022-01331
• Device Sequence Number: 20519264
• Product Code: HWC
• UDI-Device Identifier: 07613327212327
• UDI-Public: 07613327212327
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K151264
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2022

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/19/2022
• Supplement Date Received by Manufacturer: 11/16/2022
• Initial Report FDA Received Date: 09/12/2022
• Supplement Report FDA Received Date: 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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