MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CONICAL TAP 7MM; PLATE, FIXATION, BONE

Model Number	71369007
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during used in revision hip conical tap 7mm broke inside the patient the procedure finished with a smith and nephew backup device.No patient injuries reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was returned for evaluation.A visual inspection confirmed the tip is broken off the conical tap 7mm and has not been returned.The device shows significant signs of wear/usage.A medical investigation was conducted and confirms based on the information provided, although the device broke inside the patient, there was no retained foreign body and no delay reported.Per correspondence, the procedure was successfully completed with a backup s+n device without further medical interventions.It was communicated that the requested medical documentation was not available for inclusion in the medical investigation.No further patient impact beyond the modified surgical procedure would be anticipated based on the information provided.No further medical assessment is warranted at this time.A review of complaint history for the listed part revealed no prior 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.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 repeated use can occur.Expected wear/tear is likely the probable cause 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.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: CONICAL TAP 7MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10645425
• Report Number: 1020279-2020-05210
• Device Sequence Number: 2555351
• Product Code: HRS
• UDI-Device Identifier: 03596010437631
• UDI-Public: 03596010437631
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K123055
• 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): 07/22/2021

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: 71369007
• Device Catalogue Number: 71369007
• Device Lot Number: 18A5Y0021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2020
• Initial Date Received by Manufacturer: 09/09/2020
• Supplement Date Received by Manufacturer: 07/21/2021
• Initial Report FDA Received Date: 10/07/2020
• Supplement Report FDA Received Date: 07/22/2021
• 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