MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FLEXIBLE SCREWDRIVER; PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY

Model Number	71362290
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during thr procedure the flexible screwdriver is bent and needs to be replaced.The procedure was completed without delay with an smith&nephew backup device.No patient harm or additional complications were reported.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.This device is a reusable instrument 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 product 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 and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further investigation warranted for these complaints; however, we will continue to monitor for future complaints and investigate as necessary.Internal complaint reference number: (b)(4).
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).H11: further review by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The event states that the flexible screwdriver was found bent during surgery without patient harm.Event may result in a short procedural delay and/or require use of a backup device to continue procedure.This event is not likely to cause or contribute to a death or serious injury and is considered not reportable pursuant to applicable regulations.Therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If additional details confirm the occurrence of a reportable event, we will update our records accordingly and submit a subsequent report detailing both the event and our complete investigations.

• Brand Name: FLEXIBLE SCREWDRIVER
• Common Device Name: PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 1450 brooks road; memphis, TN 38116 ; 5123913905
• MDR Report Key: 11356741
• Report Number: 1020279-2021-01462
• Device Sequence Number: 13650559
• Product Code: MBH
• UDI-Device Identifier: 03596010454171
• UDI-Public: 03596010454171
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K121393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/10/2026

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: 71362290
• Device Catalogue Number: 71362290
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2021
• Supplement Date Received by Manufacturer: 03/28/2021; 03/03/2026
• Initial Report FDA Received Date: 02/21/2021
• Supplement Report FDA Received Date: 04/06/2021; 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown