MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BONE TUNNEL PLUG LARGE 10-11MM; ACCESSORIES,ARTHROSCOPIC

Model Number	013562
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/03/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during arthroscopy surgery, the bone tunnel plug was placed in order to not make serum from the tunnel, following the patient's knee was bent, the plug broke.A piece of the plug was inside the tunnel, but it was removed successfully and there was no need to use a backup.There was a delay of under 30 min, the procedure was completed without further complications.
Additional Manufacturer Narrative
The reported bone tunnel plug large 10-11mm used in treatment, has not been returned for evaluation, however a photograph was supplied.Examination of the [photograph confirmed the reported breakage.The distal end of the plug has broken off.The bone tunnel plug is over five years old and looks worn.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive force place on the device during use.The instruction for use outlines precautionary statements and instructions in during deployment.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.A review of the manufacturing and complaint records was performed for the reported lot, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: BONE TUNNEL PLUG LARGE 10-11MM
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10323381
• Report Number: 1219602-2020-01131
• Device Sequence Number: 16881819
• Product Code: NBH
• UDI-Device Identifier: 03596010091147
• UDI-Public: 03596010091147
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2020

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
• Operator of Device: Health Professional
• Device Model Number: 013562
• Device Catalogue Number: 013562
• Device Lot Number: 50530889
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/06/2020
• Supplement Date Received by Manufacturer: 09/02/2020
• Initial Report FDA Received Date: 07/24/2020
• Supplement Report FDA Received Date: 09/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 22 YR