MAUDE Adverse Event Report: STRYKER SPINE-US ANCHOR C SCREWDRIVER - STRAIGHT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	48328500
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	12/11/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of screwdriver broke off intra-op.All broken fragments were retrieved successfully.No delay, no medical intervention, and no adverse consequences were reported with this event.
Additional Manufacturer Narrative
Method: visual inspection, product history review, complaint history review, nc/capa history review, labelling review, risk assessment result: the reported event was confirmed via visual inspection of the returned device.Per visual inspection, wear and deformation was identified around broken tip.The device was approximately 8 years old at the time of the event.Manufacturing files were reviewed and no revealed anomalies were found.Conclusion: the most likely root cause of the tip fracture is normal wear due to device age.
Event or Problem Description
It was reported that the tip of screwdriver broke off intra-op.All broken fragments were retrieved successfully.No delay, no medical intervention, and no adverse consequences were reported with this event.

• Brand Name: ANCHOR C SCREWDRIVER - STRAIGHT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8203663
• Report Number: 0009617544-2018-00307
• Device Sequence Number: 11461140
• Product Code: LXH
• UDI-Device Identifier: 07613327267082
• UDI-Public: 07613327267082
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2019

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: Health Professional
• Device Catalogue Number: 48328500
• Device Lot Number: 111872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2018
• Initial Date Received by Manufacturer: 12/11/2018
• Supplement Date Received by Manufacturer: 03/15/2019
• Initial Report FDA Received Date: 12/28/2018
• Supplement Report FDA Received Date: 04/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1