MAUDE Adverse Event Report: STRYKER SPINE-FRANCE SLIDE INTEGRATED DISTRACTOR INSERTER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	48361220
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/06/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of threaded t-handle broke while inserting implant to the inserter.Nothing broke inside the patient.
Additional Manufacturer Narrative
Lot# 121474.Method: visual inspection; device history review; complaint history review; risk assessment.Results: the returned device was confirmed to have its tip fractured via visual inspection.No relevant manufacturing issues were found that may have contributed to the reported failure upon manufacturing history review.Conclusion: the manufacturing history review revealed the age of the device to be almost 4 years.The ifu for the instruments states that the instruments may fracture depending on the age of the device, the number of times they are used as well as the precautions taken in handling, cleaning and storage.Therefore the probable root cause of the reported event is noral wear and tear of instruments.
Event or Problem Description
It was reported that the tip of threaded t-handle broke while inserting implant to the inserter.Nothing broke inside the patient.

• Brand Name: SLIDE INTEGRATED DISTRACTOR 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: 5689204
• Report Number: 0009617544-2016-00211
• Device Sequence Number: 385084
• Product Code: LXH
• UDI-Device Identifier: 07613327269062
• UDI-Public: (01)07613327269062
• 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): 05/06/2016

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: 48361220
• Device Lot Number: 121474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/06/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/31/2016
• Supplement Report FDA Received Date: 08/05/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1