MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BONE TUNNEL PLUG SMALL 7MM; ACCESSORIES,ARTHROSCOPIC

Catalog Number	013560
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/17/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during treatment device broke.All pieces were removed.It is unknown if a back-up device was available or if there was delay on the procedure.No patient injury or other complications were reported.
Additional Manufacturer Narrative
Device has not been returned for evaluation.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive force.As with any surgical instrument, careful attention should be exercised to ensure that excessive force is not placed on the instrument.Excessive force can result in instrument failure.
Event or Problem Description
It was reported that during lca procedure, the device broke.All pieces were removed.A back up device was available and no delay was reported.No patient injury or other complications were reported.
Event or Problem Description
It was reported that during lca procedure, the device broke.All pieces were removed.A back up device was available and no delay was reported.No patient injury or other complications were reported.
Additional Manufacturer Narrative
One 7mm bone plug was returned for evaluation.Visual assessment of the device confirmed the reported breakage.The distal end of the device has broken off and was not returned for evaluation.As reported the patients knee was flexed causing the reported breakage.Per the device instruction for use excessive force can result in instrument failure.The instruction for use was reviewed and was found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: BONE TUNNEL PLUG SMALL 7MM
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8541671
• Report Number: 1219602-2019-00451
• Device Sequence Number: 16758820
• Product Code: NBH
• UDI-Device Identifier: 03596010091123
• UDI-Public: 03596010091123
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: D164484
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/02/2019

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 Catalogue Number: 013560
• Device Lot Number: GRA033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2019
• Initial Date Received by Manufacturer: 04/18/2019
• Supplement Date Received by Manufacturer: 06/03/2019; 08/30/2019
• Initial Report FDA Received Date: 04/23/2019
• Supplement Report FDA Received Date: 06/04/2019; 09/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1