MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHOLOGY ANTERIOR BROACH HDLE KIT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	71365230KT
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint reference: case (b)(4).
Event or Problem Description
It was reported that sizing issues with the anthology case were noticed.It was not possible to attribute the issue to any particular instrument and there is no singular surgery to cite.No further information reported.
Additional Manufacturer Narrative
The devices, intended for use in treatment, were returned for evaluation.A visual inspection of the returned devices found the devices to be dull.These devices show signs of extensive use.The dimensional evaluation could not explain or confirm the stated failure mode.The returned devices are within the drawing specification and tolerances.The tooth profile of the returned broaches was verified with their respective overlays.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 manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.These devices are reusable instruments that can be exposed to numerous surgeries; damage from repeated use can occur.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.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 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: ANTHOLOGY ANTERIOR BROACH HDLE KIT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10912552
• Report Number: 1020279-2020-06796
• Device Sequence Number: 11592535
• Product Code: LXH
• UDI-Device Identifier: 00885556202845
• UDI-Public: 00885556202845
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71365230KT
• Device Catalogue Number: 71365230KT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2021
• Initial Date Received by Manufacturer: 11/03/2020
• Supplement Date Received by Manufacturer: 04/22/2021
• Initial Report FDA Received Date: 11/26/2020
• Supplement Report FDA Received Date: 04/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1