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

Catalog Number	013560
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Foreign post code - (b)(6).
Event or Problem Description
It was reported, during an unspecified surgery, the bone tunnel plug broke its tip inside the joint.The fragment was removed.It is unknown if/how the surgery was completed.The surgery was not delayed.The patient was not injured.
Additional Manufacturer Narrative
The reported 7mm bone tunnel plug intended for use in treatment, was not returned for evaluation.Without the reported product a visual evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, plug broke during use.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive forces applied during use.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: 8684726
• Report Number: 1219602-2019-00665
• Device Sequence Number: 2523112
• Product Code: NBH
• UDI-Device Identifier: 03596010091123
• UDI-Public: 03596010091123
• 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): 07/10/2019

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: 50506541
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/22/2019
• Supplement Date Received by Manufacturer: 07/09/2019
• Initial Report FDA Received Date: 06/10/2019
• Supplement Report FDA Received Date: 07/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1