MAUDE Adverse Event Report: SMITH & NEPHEW, INC. STD DRILL GUIDE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	71654502
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/17/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the procedure, when the surgeon was performing a tibial nail and hit the impactor, the teeth of the drill guide was broke.All pieces were recovered.The procedure had a delay between 0-30 min and the surgery was finish using a backup from smith&nephew.No patient injury or other complications were reported.The surgeon was satisfied with the surgical outcome and did not blame the device.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
Results of investigation: the device, used in treatment, was returned for evaluation.The clinical/medical team concluded, per report, all of the broken pieces were recovered from the patient.The procedure was completed using a back-up without delay.Per e-mail communication no patient injury occurred due to the additional surgical time.Since no adverse events are being reported due to the reported event, no further medical assessment is warranted.A visual inspection confirmed the posts are damaged on the std drill guide.The device shows significant signs of wear/usage.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 have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management files revealed that this failure mode has been identified.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.This is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.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 warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: STD DRILL GUIDE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10543714
• Report Number: 1020279-2020-04630
• Device Sequence Number: 3124331
• Product Code: HSB
• UDI-Device Identifier: 03596010585837
• UDI-Public: 03596010585837
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K122170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2021

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: 71654502
• Device Catalogue Number: 71654502
• Device Lot Number: 07LAF0026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2020
• Initial Date Received by Manufacturer: 08/23/2020
• Supplement Date Received by Manufacturer: 04/17/2021
• Initial Report FDA Received Date: 09/16/2020
• Supplement Report FDA Received Date: 05/08/2021
• 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