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

Model Number	71674540
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/14/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the customer attempted to use the combined integrated lag and compression screw method into the neck of femur, however once the compression starter drill was used it appeared to catch on the jig/nail causing significant drill damage and insufficient drill depth for the compression screw.As an alternative the decision was made to use a single lag screw instead which again came into contact with the jig/nail and caused significant damage to the lag screw.No more information provided.
Additional Manufacturer Narrative
The devices, used in treatment, were not returned for evaluation.The photo provided confirmed the tip is broken on the drill.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.The devices are reusable instruments that can be exposed to numerous surgeries; damage from repeated use can occur.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.

• Brand Name: INTERTAN LAG SCREW DRILL
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9038252
• Report Number: 1020279-2019-03349
• Device Sequence Number: 1743398
• Product Code: HSB
• UDI-Device Identifier: 00885556363348
• UDI-Public: 00885556363348
• Combination Product (Y/N): N
• PMA/510(K) Number: K122170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2020

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 Model Number: 71674540
• Device Catalogue Number: 71674540
• Device Lot Number: UNKNOWN/UNREADABLE
• Initial Date Received by Manufacturer: 08/14/2019
• Supplement Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 09/13/2019
• Supplement Report FDA Received Date: 04/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1