MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MOSAICPLASTY DP-DISP. 8.5MM; ACCESSORIES,ARTHROSCOPIC

Catalog Number 7209237

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/28/2019

Event Type  malfunction  

Event Description

It was reported that during a mosaicplasty with the 8.5mm kit, they tried to remove the first graft and the bone plug bit it did not bring the trephine, then they tried a second time and the same thing happened, device performed the cut, but this did not bring the graft, they did it 4 times.The procedure was completed with a back up device with no patient injuries.A delay greater than 30 minutes was reported.

Manufacturer Narrative

Visual inspection and functional testing could not be performed because the device in question has not been returned for evaluation.Thus, the complaint could not be verified and a root cause could not be determined with confidence.It is difficult to perform an accurate evaluation of a failure without having the failed product.As such the complaint is being closed without conclusion.However, if the product is returned in the future the complaint can be reopened and evaluated.

Event Description

It was reported that during a mosaicplasty with the 8.5mm kit, they tried to remove the first graft and the bone plug bit it did not bring the trephine, then they tried a second time and the same thing happened, device performed the cut, but this did not bring the graft, they did it 4 times.The procedure was completed with the same device with no patient injuries.A delay greater than 30 minutes was reported.

Manufacturer Narrative

One 8.5mm disposable mosaiplasty kit was returned for evaluation.Visual assessment of the tubular chisel showed no abnormalities.Dimensional assessment of the device confirmed it met print specifications.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: rotating the chisel instead of toggling the chisel to break off the graft.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: MOSAICPLASTY DP-DISP. 8.5MM
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8437402
• MDR Text Key: 139425280
• Report Number: 1219602-2019-00318
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010473158
• UDI-Public: 03596010473158
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2021
• Device Catalogue Number: 7209237
• Device Lot Number: 50638442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2019
• Initial Date Manufacturer Received: 03/01/2019
• Initial Date FDA Received: 03/20/2019
• Supplement Dates Manufacturer Received: 03/15/2019; 04/19/2019; 07/29/2019
• Supplement Dates FDA Received: 03/21/2019; 04/22/2019; 08/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1