MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVS AL TRIAL INSERTER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.

Catalog Number	48329800
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/29/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a trial inserter and a trial broke on the threads.
Additional Manufacturer Narrative
Method: risk assessment.Results: per email correspondence with the sales rep, the device was reported to be used 100-150 times.According to the general ifu for instruments, "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 plausible root cause of this event can be normal wear and tear of instrument, which led to the threading fracture of the inserter into the trial.
Event or Problem Description
It was reported that a trial inserter and a trial broke on the threads.

• Brand Name: AVS AL TRIAL INSERTER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5514554
• Report Number: 0009617544-2016-00122
• Device Sequence Number: 498683
• Product Code: LXH
• UDI-Device Identifier: 07613327267839
• UDI-Public: (01)07613327267839
• Combination Product (Y/N): N
• 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): 02/29/2016

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: 48329800
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/29/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/21/2016
• Supplement Report FDA Received Date: 06/10/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1