MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PLUG BONE TUNNEL 9/10 MED.; ACCESSORIES,ARTHROSCOPIC

Catalog Number	013561
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/17/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a knee arthroscopy+lca surgery the device broke off inside the tibia tunnel, as per reporter the broken pieces were retrieved immediately with a shave.No patient injuries or delay reported.Surgery was finished using the same device.
Additional Manufacturer Narrative
The reported bone tunnel plug intended for use in treatment, has not been returned for evaluation.Without the reported product a visual evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, the plug broke during use.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: use of excessive force during use.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: PLUG BONE TUNNEL 9/10 MED.
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8910384
• Report Number: 1219602-2019-00987
• Device Sequence Number: 16832469
• Product Code: NBH
• UDI-Device Identifier: 03596010091130
• UDI-Public: 03596010091130
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2019

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: 013561
• Device Lot Number: 504573030
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/24/2019
• Supplement Date Received by Manufacturer: 09/10/2019
• Initial Report FDA Received Date: 08/20/2019
• Supplement Report FDA Received Date: 09/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 16 YR