MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHOLOGY INSERTER POSTER HARD; PRSTHSS,HP,SM-CNSTRND, MTL/CRMC/PLYMR,CEMENTEDORNON-POROUS,UNCEMENTED

Catalog Number 71365705

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/27/2020

Event Type  malfunction  

Event Description

It was reported that during inspection it was found that the handle is broken off.No case involved.No injury reported.

Manufacturer Narrative

The device, intended for use treatment was not returned for evaluation, reporting event could not be confirmed.Therefore, product analysis could not be performed at this time.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 device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.This device is a reusable instrument 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.

• Brand Name: ANTHOLOGY INSERTER POSTER HARD
• Type of Device: PRSTHSS,HP,SM-CNSTRND, MTL/CRMC/PLYMR,CEMENTEDORNON-POROUS,UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10089820
• MDR Text Key: 192143817
• Report Number: 1020279-2020-01864
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 03596010555663
• UDI-Public: 3596010555663
• Combination Product (y/n): N
• PMA/PMN Number: K113789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/16/2020
• Device Catalogue Number: 71365705
• Device Lot Number: 08KM00707
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 04/27/2020
• Date Manufacturer Received: 08/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1