MAUDE Adverse Event Report: DEPUY SPINE INC EAGLE+/SWIFT+ SCR REMOVAL TOOL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	286560000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/01/2017
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 re-positioning a plate.He had a difficult time remounting the screws and broke or stripped some of the drivers.Upon inspection some of the threads on the screws were messed up so the surgeon did not feel comfortable putting those back in and that they would still be blocked by the clocking ring.
Additional Manufacturer Narrative
Product complaint # (b)(4).The eagle/swift plus screw removal tool features a fractured tip.The instrument and its tip were submitted for fracture analysis.Optical imaging of the fracture sites show plastic deformation at the hexlobes and torsional shear markings following a circular pattern.This suggests the driver underwent a quasi-static torsional shear failure.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.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.The root cause of the instrument tip breaking cannot be determined from the sample and the information provided.The results of fracture analysis have determined that a probable root cause is torsional 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).

• Brand Name: EAGLE+/SWIFT+ SCR REMOVAL TOOL
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7138254
• Report Number: 1526439-2017-50116
• Device Sequence Number: 1068340
• Product Code: LXH
• UDI-Device Identifier: 10705034213088
• UDI-Public: 10705034213088
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 12/01/2017

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: 286560000
• Device Lot Number: GM4064201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2017
• Initial Date Received by Manufacturer: 12/01/2017
• Supplement Date Received by Manufacturer: 12/01/2017; 02/27/2018
• Initial Report FDA Received Date: 12/21/2017
• Supplement Report FDA Received Date: 12/21/2017; 02/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR