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

Catalog Number	71152151
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/08/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that screw removal wrench broke during removal of the lag screw.It is unknown if revision surgery was performed.No delay was reported and is unknown if snn backup device was used or required.
Additional Manufacturer Narrative
Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that this a duplicate complaint, in other words, this report has been already addressed in device (b)(4), therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.
Event or Problem Description
It was reported that, during surgery, screw removal wrench broke during removal of the lag screw.No delay was reported and procedure was completed by pushing the centering sleeve in and revealing the end of the lag screw.The retaining rod was cut to allow the removal wrench to attach to the lag screw as only a tiny bit of the end of the lag screw was revealed.No delay and no harm to patient reported.

• Brand Name: LAG SCREW REMOVAL WRENCH
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8380842
• Report Number: 1020279-2019-00879
• Device Sequence Number: 2029710
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/02/2019

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: 71152151
• Device Lot Number: 14CCT0005
• Initial Date Received by Manufacturer: 02/08/2019
• Supplement Date Received by Manufacturer: 02/08/2019; 04/16/2019
• Initial Report FDA Received Date: 02/28/2019
• Supplement Report FDA Received Date: 03/06/2019; 05/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1