MAUDE Adverse Event Report: DEPUY SYNTHES SPINE KERRISON APPROXIMATOR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	274655100
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	11/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
The surgeon was trying to place the reducer under the head of the polyaxial screw and while he was doing that, twisted it left and right to maneuver it under the head of the screw and the tip broke off.
Additional Manufacturer Narrative
Visual examination at the macroscopic level revealed that the instrument¿s distal tip had become fractured.The fractured tip was not provided for analysis.Device was then sent for fracture analysis.The fracture analysis report notes that the fractured surface exhibits rough surface characteristics that extend across the entire surface suggesting that the tip underwent a static overload failure.No material defects or other abnormalities have been identified in the fracture analysis report.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.A trend analysis was conducted.No emerging trends were found requiring further actions.A definitive root cause for the instrument¿s distal tip becoming fractured cannot be positively determined.However, the fracture analysis report notes that the fractured surface exhibits rough surface characteristics that extend across the entire surface suggesting that the tip underwent a static overload failure.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends were found, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Device received at investigation site on 11/9/2017.

• Brand Name: KERRISON APPROXIMATOR
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7062376
• Report Number: 1526439-2017-50017
• Device Sequence Number: 11102277
• Product Code: LXH
• UDI-Device Identifier: 10705034193175
• UDI-Public: 10705034193175
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• 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,Followup
• Report Date (Section B): 10/31/2017

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: Health Professional
• Device Catalogue Number: 274655100
• Device Lot Number: 0106DC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2017
• Initial Date Received by Manufacturer: 11/02/2017
• Supplement Date Received by Manufacturer: 11/09/2017; 12/01/2017
• Initial Report FDA Received Date: 11/27/2017
• Supplement Report FDA Received Date: 12/04/2017; 12/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR