MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ARTHRO-ROUND XL; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Catalog Number	72202586
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/01/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a hip arthroscopy procedure after anchoring the anchor, the tip of the clamp broke inside the patient; all pieces were removed with a vacuum.No delay or patient injury reported.It is unknown how the issue was resolved.
Additional Manufacturer Narrative
The reported anthro round xl intended for use in treatment, was not returned for evaluation.Without the reported product a visual and functional evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, the device disassembled.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive force applied.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive forces applied.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: ARTHRO-ROUND XL
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8814422
• Report Number: 1219602-2019-00855
• Device Sequence Number: 3027214
• Product Code: MDM
• UDI-Device Identifier: 03596010651433
• UDI-Public: 03596010651433
• 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): 08/19/2019

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: 72202586
• Device Lot Number: 50533108
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/02/2019
• Supplement Date Received by Manufacturer: 08/16/2019
• Initial Report FDA Received Date: 07/22/2019
• Supplement Report FDA Received Date: 08/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 21 YR