MAUDE Adverse Event Report: STRYKER SPINE-FRANCE SLIDE IMPLANT BLOCKER 16MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.

Catalog Number	48361226
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/22/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while putting in implant, prongs that hold the implant onto the block broke off.We opened a new tray and used new block and slide to complete the procedure.
Additional Manufacturer Narrative
Device history review, complaint history review, risk assessment; no relevant manufacturing issues were found that may have led to the reported event.Dhr review of the reported the device revealed the age of the device to be almost 8 years.According to the general instrument ifu, 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.The probable root cause of the reported event is determined to be normal wear and tear of instruments.
Event or Problem Description
It was reported that while putting in implant, prongs that hold the implant onto the block broke off.We opened a new tray and used new block and slide to complete the procedure.

• Brand Name: SLIDE IMPLANT BLOCKER 16MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5877454
• Report Number: 0009617544-2016-00337
• Device Sequence Number: 13541146
• Product Code: LXH
• UDI-Device Identifier: 07613327269123
• UDI-Public: (01)07613327269123
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2016

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: 48361226
• Device Lot Number: 084508
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/11/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/22/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/15/2016
• Supplement Report FDA Received Date: 10/13/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1