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

Catalog Number	71050031
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/10/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the spring inside of the t-handle was beat up.Procedure was completed with competitor's device.
Additional Manufacturer Narrative
The pin insertion wrench was returned and evaluated.A visual inspection found that the spring inside the stem shows no obvious signs of damage.A functional inspection found that the device was able to hold the corresponding part as intended.We recommend that all reusable instruments be routinely inspected for wear and damage so they can be replaced as necessary.A review of the complaint history for the associated batch did not reveal additional complaints.Reviewing the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Based on this investigation, the need for corrective action is not indicated.No additional actions are being taken at this time; however we will continue to monitor for future complaints and investigate further as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: PIN INSERTION WRENCH
• Common Device Name: PIN, FIXATION, THREADED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7896272
• Report Number: 1020279-2018-01920
• Device Sequence Number: 2347389
• Product Code: JDW
• UDI-Device Identifier: 03596010510938
• UDI-Public: 03596010510938
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K120871
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2018

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: 71050031
• Device Lot Number: 13GM00484
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2018
• Initial Date Received by Manufacturer: 08/21/2018
• Supplement Date Received by Manufacturer: 08/21/2018
• Initial Report FDA Received Date: 09/20/2018
• Supplement Report FDA Received Date: 11/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1