MAUDE Adverse Event Report: STRYKER SPINE-US REFLEX-HYBRID 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	02/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a reflex-hybrid screwdriver "broke" intra-operatively.Surgery was successfully completed with no delay.No adverse consequences or medical intervention were reported.
Event or Problem Description
It was reported that a reflex-hybrid screwdriver "broke" intra-operatively.Surgery was successfully completed with no delay.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
Additional information: d4, d9, h3 have been updated to reflect receipt of the device and device lot number.
Event or Problem Description
It was reported that the tip of a reflex-hybrid screwdriver fractured intra-operatively.The procedure was completed successfully with no surgical delay and no adverse consequence to the patient.
Additional Manufacturer Narrative
Tip fracture was confirmed via visual inspection of the returned device.Wear and discoloration was identified on the teeth indicating extensive use after release.Complaint history was reviewed and no similar complaints for the reported catalogue number were identified.Device history records were reviewed and no relevant manufacturing issues were identified.The device has been in use for approximately 3.5 years.Based on the visual inspection and device age, the root cause of the reported event is most likely normal wear and tear.Factors such as consistent use of the instrument throughout its lifetime may cause fatigue and contribute to fracture.

• Brand Name: REFLEX-HYBRID 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: 13559997
• Report Number: 0009617544-2022-00017
• Device Sequence Number: 4195244
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/08/2022

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: 48510800
• Device Catalogue Number: 48510800
• Device Lot Number: 141381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2022
• Supplement Date Received by Manufacturer: 03/25/2022; 05/10/2022
• Initial Report FDA Received Date: 02/18/2022
• Supplement Report FDA Received Date: 04/20/2022; 06/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2018
• 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