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 Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/22/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during procedure the tip of the conical tap 7mm broke inside of the patient.The piece could not be recovered.A surgical delay no greater than 30 min was reported.
Event or Problem Description
It was reported that during procedure the tip of the conical tap 7mm broke inside of the patient.The piece could not be recovered.A revision surgery was required.
Additional Manufacturer Narrative
Results of investigation: it was reported that during procedure the tip of the conical tap 7mm broke inside of the patient.The piece could not be recovered.A revision surgery was required.The associated device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.As lot information was not made available, device history record review cannot be completed.At this time, there is no information available to suspect that the product 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 risk management files that the reported failure was documented appropriately.Based on this investigation, the need for corrective action is not indicated.A medical analysis noted that no adequate materials has not been received to fully evaluate the complaint.Excessive pressure, the age of the instrument or other procedural variances cannot be ruled out as a contributed factor of the reported event.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.We consider this investigation closed.Correction g1.

• 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: 10434810
• Report Number: 1020279-2020-04113
• Device Sequence Number: 3446632
• Product Code: HRS
• UDI-Device Identifier: 03596010437631
• UDI-Public: 03596010437631
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/15/2021

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: 71369007
• Device Catalogue Number: 71369007
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/29/2020
• Supplement Date Received by Manufacturer: 10/08/2020; 01/19/2021
• Initial Report FDA Received Date: 08/20/2020
• Supplement Report FDA Received Date: 10/08/2020; 02/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 87 YR