MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FEMORAL HEAD/NECK IMPACTOR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number 71360093

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/25/2020

Event Type  Injury  

Event Description

It was reported that during thr procedure the plastic of the femoral head/neck impactor got damaged.This happened during use outside the patient.There was no reported delay.Procedure concluded with a competitor device.No injuries or other complications were reported at this time.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

Lot number and expiration date added the device, used in treatment was returned for evaluation.Visual inspection of the returned device confirms that the device is damaged and has signs of wear and tear from use.According to clinical/medical investigation, this case reports the plastic component of the femoral head pusher was damaged during surgery.Per complaint detail, there was no patient injury or surgical delay, and the procedure was completed using a competitor device.Since no patient harm is alleged, no further clinical assessment is warranted.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 review of complaint history for the listed part revealed no prior complaints for the lot.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.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further actions are being taken at this time.

• Brand Name: FEMORAL HEAD/NECK IMPACTOR
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10844435
• MDR Text Key: 216388581
• Report Number: 1020279-2020-06481
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 03596010619310
• UDI-Public: 03596010619310
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71360093
• Device Catalogue Number: 71360093
• Device Lot Number: 20AM06938
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/25/2020
• Initial Date FDA Received: 11/16/2020
• Supplement Dates Manufacturer Received: 02/04/2021
• Supplement Dates FDA Received: 02/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention