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

Model Number	71674523
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/13/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the 3.2 guide pin sleeve was difficult to remove from the lag screw drill sleeve during surgery.The surgeon had difficulty removing it and had to use other instrumentation to pull it out.It is unknown if there was a delay or how the procedure was finished.
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 the device will be evaluated and sent to other complaint, 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.

• Brand Name: LAG SCREW DRILL SLEEVE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10788797
• Report Number: 1020279-2020-06184
• Device Sequence Number: 2959848
• Product Code: HSB
• UDI-Device Identifier: 00885556363249
• UDI-Public: 00885556363249
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K122170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 71674523
• Device Catalogue Number: 71674523
• Initial Date Received by Manufacturer: 10/13/2020
• Supplement Date Received by Manufacturer: 11/06/2020
• Initial Report FDA Received Date: 11/04/2020
• Supplement Report FDA Received Date: 11/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention