MAUDE Adverse Event Report: SMITH & NEPHEW, INC. QUICK CPLG OSTEO HAND SHORT; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 71367548

Device Problem Disconnection (1171)

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

Event Date 07/27/2020

Event Type  Injury  

Event Description

It was reported that, during use in surgery, the quick cplg osteo hand short was not holding the osteo blade correctly.The procedure was finished using a similar device made by s&n.Surgery was not delayed.The patient was not harmed.

Manufacturer Narrative

H3, h6: the device, used in treatment was returned for evaluation.Visual inspection of the returned device confirms that the device has signs of wear and tear from use.According to functional evaluation, the device osteo hand short is worn out and doesn't hold the osteo blade in place.According to clinical/medical investigation, the device not holding the osteo blade correctly during a revision hip arthroplasty.Per email communication, the procedure was completed with a similar, well functioning s&n device.No patient injury or surgical extension was reported.Therefore, no further medical assessment can be rendered at this time.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.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.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.No further actions are being taken at this time.We consider this investigation closed.Credit will be issued for the device.

• Brand Name: QUICK CPLG OSTEO HAND SHORT
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10437372
• MDR Text Key: 203859485
• Report Number: 1020279-2020-04128
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 03596010402783
• UDI-Public: 03596010402783
• Combination Product (y/n): N
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 08/12/2021

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: 71367548
• Device Catalogue Number: 71367548
• Device Lot Number: 17LSY0017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2020
• Initial Date Manufacturer Received: 07/27/2020
• Initial Date FDA Received: 08/21/2020
• Supplement Dates Manufacturer Received: 08/11/2021
• Supplement Dates FDA Received: 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention