MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LARGE SCREWDRIVER HANDLE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	71173547
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during trauma surgery, a peri-loc large screwdriver handle broke inside the patient.Surgery was resumed, without any delay, with a smith & nephew back-up device.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device did not confirm the stated failure mode.A functional evaluation of the returned device could not confirm the stated failure mode.The device functions as intended.The clinical/medical evaluation concluded that this case reports the breakage of the peri-loc large screwdriver handle during use inside of the patient.However, it is unknown if there are broken pieces that were not recovered from the patient.No clinically relevant supporting documentation was provided for inclusion in this medical investigation.Therefore, the root cause of the reported peri-loc large screwdriver handle breakage could not be determined.The peri-loc screwdriver handles are manufactured and intended as externally communicating devices and are not approved for long term internal tissue exposure and long-term implantation data is not available.The patient impact beyond possibility of micro-motion and/or migration and local irritation/discomfort cannot be determined.Per report, surgery was resumed, without any delay, with a smith & nephew back-up device.Patient was not injured as consequence of this problem.Therefore, no further medical assessment can be rendered 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.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 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 future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: LARGE SCREWDRIVER HANDLE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12130010
• Report Number: 1020279-2021-05782
• Device Sequence Number: 11619850
• Product Code: HSB
• UDI-Device Identifier: 03596010519580
• UDI-Public: 03596010519580
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2021

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: 71173547
• Device Catalogue Number: 71173547
• Device Lot Number: 495667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2021
• Initial Date Received by Manufacturer: 06/23/2021
• Supplement Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 07/07/2021
• Supplement Report FDA Received Date: 09/15/2021
• 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