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

Model Number 71365230KT

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/03/2020

Event Type  malfunction  

Manufacturer Narrative

Complaint reference: case (b)(4).

Event 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.

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
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10912552
• MDR Text Key: 218507875
• Report Number: 1020279-2020-06796
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00885556202845
• UDI-Public: 00885556202845
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 04/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1