MAUDE Adverse Event Report: SMITH AND NEPHEW, INC. LAG SCREW REMOVAL WRENCH; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	71152151
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/11/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device did not remove the lag screw.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.A visual inspection of the returned lag screw removal wrench indicated that the long retaining screw's threads are damaged, potentially causing connection issues.The long barrel guide was not returned.A review of complaint history on the listed part revealed no prior complaints for the listed batch.A review of 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.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: LAG SCREW REMOVAL WRENCH
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH AND NEPHEW, INC.; 1450 brooks road; memphis, tennessee; memphis 38116
• MDR Report Key: 7935410
• Report Number: 1020279-2018-02102
• Device Sequence Number: 16482701
• Product Code: HSB
• UDI-Device Identifier: 03596010519092
• UDI-Public: 03596010519092
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K122170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2018

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: 71152151
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/14/2018
• Supplement Date Received by Manufacturer: 09/14/2018
• Initial Report FDA Received Date: 10/04/2018
• Supplement Report FDA Received Date: 11/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1