MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS TAP SLEEVE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.

Model Number	48561914
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	04/11/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the spring inside tap sleeve is not in place and is impeding you from placing the tap.
Additional Manufacturer Narrative
Visual inspection, device history review, complaint history review, risk assessment.The device was confirmed visually to have a deformed inner spring.Manufacturing records for this product were reviewed and no anomalies were found.The probable root cause is normal wear due to instrument age.
Event or Problem Description
It was reported that the spring inside tap sleeve is not in place and is impeding you from placing the tap.

• Brand Name: OASYS TAP SLEEVE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6554084
• Report Number: 0009617544-2017-00195
• Device Sequence Number: 980942
• Product Code: LXH
• UDI-Device Identifier: 07613327271614
• UDI-Public: (01)07613327271614
• 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: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2017

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 Model Number: 48561914
• Device Catalogue Number: 48561914
• Device Lot Number: 07E852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2017
• Initial Date Received by Manufacturer: 04/11/2017
• Supplement Date Received by Manufacturer: 04/11/2017
• Initial Report FDA Received Date: 05/09/2017
• Supplement Report FDA Received Date: 07/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1