MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FIXATION BOLT WRENCH; PIN, FIXATION, THREADED

Catalog Number	102911
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, fragment of the 90-degree wrench broke off when tightening a bolt during normal use.No delay or injury reported.A backup device was not available.
Additional Manufacturer Narrative
The associated fixation bolt wrench was not returned for evaluation.However, device details were provided.Thus, a review of device history record and complaint history were performed.The device was manufactured in 2015.The review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.The review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.There is no information that would suggest the device failed to meet specifications.A relationship, if any, between the device and the reported incident could not be corroborated.No further investigation is warranted for this complaint; however, smith and nephew will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, this complaint will be reopened and reevaluated.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: FIXATION BOLT WRENCH
• Common Device Name: PIN, FIXATION, THREADED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8307908
• Report Number: 1020279-2019-00394
• Device Sequence Number: 19098761
• Product Code: JDW
• UDI-Device Identifier: 03596010031839
• UDI-Public: 03596010031839
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2019

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: 102911
• Device Lot Number: 15KTF0003
• Initial Date Received by Manufacturer: 01/11/2019
• Supplement Date Received by Manufacturer: 01/11/2019
• Initial Report FDA Received Date: 02/05/2019
• Supplement Report FDA Received Date: 04/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1