MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FEMORAL HEAD/NECK IMPACTOR; PROSTHESIS,HIP,SEMI-CNSTRND,UNCEMENTED,METAL/PLYMR,NON-POROUS,CALICUM-PHSPHT

Catalog Number 71360093

Device Problem Break (1069)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/05/2020

Event Type  malfunction  

Event Description

It was reported that during efip inspection the plastic tip was found broke off.No patient involvement.

Manufacturer Narrative

The device, intended for use in treatment was returned for evaluation.Visual inspection of the returned device confirms that the device is broken and has signs of wear and tear from use.The device was manufactured in 2015.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.The device is a reusable device that can be exposed to numerous surgeries and cleaning cycles.Probable causes that could contribute to the reported event, as reusable instruments are susceptible to damage from prolonged use and through misuse or rough handling.To avoid compromised performance or damage, it is recommended the device be inspected prior to and after each use and cleaning.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.

• Brand Name: FEMORAL HEAD/NECK IMPACTOR
• Type of Device: PROSTHESIS,HIP,SEMI-CNSTRND,UNCEMENTED,METAL/PLYMR,NON-POROUS,CALICUM-PHSPHT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10210233
• MDR Text Key: 196910888
• Report Number: 1020279-2020-02835
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: K113789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71360093
• Device Lot Number: 15CM18843
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2020
• Date Manufacturer Received: 12/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1