MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEX SCREWDRIVER SHAFT

Model Number	71170036
Medical Device Problem Codes	Use of Device Problem (1670); Defective Device (2588)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/23/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a surgical case the screwdriver did not engage the screw during insertion because the tip was worn.After that, it was switched screwdriver shafts, but the other was not much better, and because the doctor had to apply more force the screwdriver head sheered off inside the patient, but all pieces were recovered.Backup from smith&nephew was available, but it was worn (it was used).There was a 5 min delay while it brought the other hex screwdriver.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that the first device was worn; therefore a backup device was used and although, due to applied force, the screwdriver sheered off inside the patient, all pieces were reportedly recovered.Per correspondence, the procedure was completed with a 2nd backup device without significant delay (5 min) or patient injury/harm.Reportedly, wear and force were the root causes of the reported events.Based on the information provided, patient impact beyond the scant surgical delay and modified surgical procedure could not be determined; however, no patient injury or other complications were reported.No further medical assessment is warranted at this time.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file revealed this failure mode was previously identified.This device is a reusable instrument that can be exposed to numerous surgeries.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.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: HEX SCREWDRIVER SHAFT
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10160464
• Report Number: 1020279-2020-02434
• Device Sequence Number: 2823672
• Product Code: HXX
• UDI-Device Identifier: 03596010180728
• UDI-Public: 03596010180728
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/21/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71170036
• Device Catalogue Number: 71170036
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/23/2020
• Supplement Date Received by Manufacturer: 06/18/2020; 06/17/2021
• Initial Report FDA Received Date: 06/16/2020
• Supplement Report FDA Received Date: 06/18/2020; 06/21/2021
• 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