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

Model Number 71360093

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 10/06/2020

Event Type  malfunction  

Manufacturer Narrative

The associated device, intended for use in treatment, was returned and evaluated. A visual inspection of the returned device confirmed the stated failure. The impactor tip of the device is missing. The device was manufactured in 2019 and shows signs of extensive use. A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed 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. At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture. This device is a reusable instrument that can be exposed to numerous surgeries. 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.   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 is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.

Event Description

It was reported that during an office inspection it was found that the tip was of the femoral head/neck impactor missing and needs to be replaced. No case involved.

• Brand Name: FEMORAL HEAD/NECK IMPACTOR
• Type of Device: PROSTHESIS,HIP,SEMI-CNSTRND,UNCEMENTED,METAL/PLYMR,NON-POROUS,CA-PHSPHAT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 1450 brooks road; memphis, TN 38116
• MDR Report Key: 10778569
• Report Number: 1020279-2020-06065
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 03596010619310
• UDI-Public: 03596010619310
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative

Reporter Occupation

• Type of Report: Initial
• Report Date: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 71360093
• Device Catalogue Number: 71360093
• Device Lot Number: 19HM07028
• Was Device Available for Evaluation?: No Answer Provided

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse