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

Model Number	013561
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/04/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a lca procedure, the plug bone tunnel broke inside the patient's articulation.All pieces were retrieved from the patient.No delay was reported.It was not reported if a smith & nephew device was available.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: the reported medium bone tunnel plug, used 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 device broke during use.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive force applied during use.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, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.
Additional Manufacturer Narrative
D10, g4, h2, h3, h6.The reported 9/10 medium bone tunnel plug, used in treatment, has been returned for evaluation.Visual assessment of the device confirmed the reported complaint of breakage.Approximately ¾ of an inch of the distal end of the plug has been broken off and was not returned for examination.The device is severely deteriorated as the knurled head is practically nonexistent, in addition the devices surface is porous and worn.The condition of the device indicates it was subjected to an incompatible cleaning or disinfecting agent over time causing the reported breakage.The instructions 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 complaint records was performed, 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: 9558269
• Report Number: 1219602-2020-00029
• Device Sequence Number: 16738167
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/05/2020

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 Model Number: 013561
• Device Catalogue Number: 013561
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2020
• Initial Date Received by Manufacturer: 12/16/2019
• Supplement Date Received by Manufacturer: 02/17/2020; 04/29/2020
• Initial Report FDA Received Date: 01/07/2020
• Supplement Report FDA Received Date: 02/19/2020; 05/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 39 YR