MAUDE Adverse Event Report: STRYKER SPINE-US REFLEX-HYBRID FINAL-TIGHTENING SCREWDRIVER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	48510800
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device discarded by user.
Event or Problem Description
A company representative reported that a reflex-hybrid screwdriver and reflex-hybrid final tightening screwdriver broke during surgery.The procedure was completed successfully with no surgical delay and no adverse consequence to the patient.This report captures the reflex-hybrid screwdriver.
Event or Problem Description
A company representative reported that a reflex-hybrid screwdriver and reflex-hybrid final tightening screwdriver broke during surgery.The procedure was completed successfully with no surgical delay and no adverse consequence to the patient.This report captures the reflex-hybrid screwdriver.
Additional Manufacturer Narrative
The device was not returned for evaluation.Device history records could not be reviewed without either the device or a valid lot number.Complaint history was reviewed and no adverse trend for the reported catalogue number were identified.Per correspondence with field representative; the device broke during screw insertion, excess force was not applied, the angle was not difficult, broken fragments could not be retrieved from patient's cavity, and the bone quality of patient was normal.From the instructions for use: the life of the instrument depends on the number of times they are used as well as the precautions taken in handling, cleaning and storage.Great care must be taken of the instruments to ensure that they remain in good working order.A root cause cannot be established.If additional information is received or the device is returned for evaluation, the investigation will be reopened and updated.

• Brand Name: REFLEX-HYBRID FINAL-TIGHTENING SCREWDRIVER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 14570095
• Report Number: 0009617544-2022-00061
• Device Sequence Number: 20377640
• Product Code: LXH
• UDI-Device Identifier: 07613327270914
• UDI-Public: 07613327270914
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2022

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: 48510800
• Device Catalogue Number: 48510810
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2022
• Supplement Date Received by Manufacturer: 08/12/2022
• Initial Report FDA Received Date: 06/01/2022
• Supplement Report FDA Received Date: 09/09/2022
• 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
• Patient Sex: Unknown