MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA DEFORMITY 5MM BLOCKER INSERTER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	48047070
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	07/26/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; the blocker inserter was broken during the surgery.
Additional Manufacturer Narrative
(b)(4).Device history review; complaint history review; risk assessment; a similar device was sent for material analysis for the same type of failure mode.The analysis determined that the inserter broke through overload in a ductile and bending mode.This type of fracture is consistent with the user applying too much bending force to the device.The device is also 3 years old, which wear from it's extended use could have contributed to the event.No relevant manufacturing issues were identified as all units met stryker specifications.The root cause is most likely multifactorial.
Event or Problem Description
It was reported that; the blocker inserter was broken during the surgery.

• Brand Name: XIA DEFORMITY 5MM BLOCKER 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: 5885755
• Report Number: 0009617544-2016-00341
• Device Sequence Number: 403861
• Product Code: LXH
• UDI-Device Identifier: 07613327263398
• UDI-Public: (01)07613327263398
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2016

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: 48047070
• Device Lot Number: 13D261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/28/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/18/2016
• Supplement Report FDA Received Date: 10/28/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1