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

Catalog Number	7209237
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/28/2019
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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 or Problem 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.
Additional 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
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8437402
• Report Number: 1219602-2019-00318
• Device Sequence Number: 11076102
• Product Code: NBH
• UDI-Device Identifier: 03596010473158
• UDI-Public: 03596010473158
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 03/01/2019
• Supplement Date Received by Manufacturer: 03/15/2019; 04/19/2019; 07/29/2019
• Initial Report FDA Received Date: 03/20/2019
• Supplement Report FDA Received Date: 03/21/2019; 04/22/2019; 08/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1