MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BOLT 10MM; PIN, FIXATION, THREADED

Catalog Number	103200
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 upon tightening the bolt head sheared off.Delay no greater than thirty minutes was reported and backup device was available.
Additional Manufacturer Narrative
The associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The hex head fractured off of the device.Both pieces were returned.The threaded portion was returned in the pin clamp.The bolt was used instead of the set screw that comes with the pin clamp assembly.The device batch information was not provided or present on the device.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: BOLT 10MM
• Common Device Name: PIN, FIXATION, THREADED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8299099
• Report Number: 1020279-2019-00390
• Device Sequence Number: 1911880
• Product Code: JDW
• UDI-Device Identifier: 03596010031976
• UDI-Public: 03596010031976
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K994143
• 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): 03/08/2019

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: 103200
• Initial Date Received by Manufacturer: 01/11/2019
• Supplement Date Received by Manufacturer: 01/11/2019
• Initial Report FDA Received Date: 02/01/2019
• Supplement Report FDA Received Date: 03/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1