MAUDE Adverse Event Report: STRYKER SPINE-US OASYS 2K14 ADJUSTABLE DRILL GUIDE ASSY; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	48562011
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/11/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the drill guide malfunctioned during surgery.The fixation screw broke off from hand piece.The fixation screw was retrieved.No adverse consequence to patient was reported.The surgery was completed successfully.
Event or Problem Description
It was reported that the drill guide malfunctioned during surgery.The fixation screw broke off from hand piece.The fixation screw was retrieved.No adverse consequence to patient was reported.The surgery was completed successfully.
Additional Manufacturer Narrative
Method: nc/capa history review, labelling review, risk assessment.Result: the reported event was confirmed via correspondence with sales rep.Device was not returned so product inspection could not be performed.No lot# was provided so a manufacturing record review and complaint history review could not be performed.Instruments general ifu states: "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".Conclusion: the most plausible root cause of the reported event was determined to be normal wear due to extensive use.

• Brand Name: OASYS 2K14 ADJUSTABLE DRILL GUIDE ASSY
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8048509
• Report Number: 0009617544-2018-00261
• Device Sequence Number: 11144571
• Product Code: LXH
• UDI-Device Identifier: 07613327271669
• UDI-Public: 07613327271669
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2019

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: No Information
• Device Catalogue Number: 48562011
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/11/2018
• Supplement Date Received by Manufacturer: 12/28/2018
• Initial Report FDA Received Date: 11/07/2018
• Supplement Report FDA Received Date: 01/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1