MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS SMALL T8 TAPERED DR SHAFT - SHORT; NAIL, FIXATION, BONE

Catalog Number	71175078
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/08/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the head of the screw driver snapped off.A backup device was available to complete the procedure with no delay.No injury or patient impact has been confirmed yet.
Additional Manufacturer Narrative
He associated devices were returned and evaluated.A visual inspection of the returned devices confirmed the stated failure mode.The driving tips of the devices fractured off and were not returned.The devices were manufactured in 2017 and exhibit signs of extensive wear/usage.These fractures were likely caused by torsional overload.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: EVOS SMALL T8 TAPERED DR SHAFT - SHORT
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8660067
• Report Number: 1020279-2019-02111
• Device Sequence Number: 2299820
• Product Code: JDS
• UDI-Device Identifier: 00885556636084
• UDI-Public: 00885556636084
• 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,health
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2019

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: 71175078
• Device Lot Number: 17HUP0020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2019
• Initial Date Received by Manufacturer: 05/08/2019
• Supplement Date Received by Manufacturer: 05/08/2019
• Initial Report FDA Received Date: 05/31/2019
• Supplement Report FDA Received Date: 08/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1