MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 3.5MM S/R HEXDRIVER SH 178MM; SCREWDRIVER

Model Number	71173487
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during surgery two handles (tear drop screwdriver handle and large screwdriver handle) and two hexdrivers (3.5mm s/r hexdriver sh 178mm and 3.5mm cannulated hexdriver) broke as a result of trying to remove screws (inside the patient).The handle got stuck and driver could not be removed.It is unknown if there was a delay or a back up available to complete the procedure.No other complications were reported at this time.
Additional Manufacturer Narrative
Sections d and h updated.
Additional Manufacturer Narrative
A visual inspection of the returned device confirmed the stated failure mode.The device is stuck inside the handle and difficult to remove, rendering the device inoperative.The device shows signs of extensive use.The clinical/medical investigation concluded that without the requested relevant clinical information/documents a root cause of the reported breakage cannot be determined, however, per the visual inspection, we cannot rule out wear, tear and use as the likely cause of the reported failure.Should any of the broken non-implantable fragments remain inside of the patient, we cannot rule out the possibility of local skin irritation, corrosion and micro-motion/ and or migration.The future impact to the patient beyond that which has already been reported cannot be determined.It is unknown if there was a backup device or procedural delay.Since no other complications were reported, no further clinical/medical assessment is warranted at this time.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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: 3.5MM S/R HEXDRIVER SH 178MM
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10928630
• Report Number: 1020279-2020-06876
• Device Sequence Number: 14034040
• Product Code: HXX
• UDI-Device Identifier: 03596010629753
• UDI-Public: 03596010629753
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 08/05/2021

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: 71173487
• Device Catalogue Number: 71173487
• Device Lot Number: 06HM08020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Initial Date Received by Manufacturer: 11/09/2020
• Supplement Date Received by Manufacturer: 12/23/2020; 08/04/2021
• Initial Report FDA Received Date: 12/01/2020
• Supplement Report FDA Received Date: 12/28/2020; 08/05/2021
• 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