MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ACUFEX PRO-OVAL UPBITER PUNCH; ACCESSORIES,ARTHROSCOPIC

Model Number	7207083
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during an unknown procedure, the mandible of the acufex broke and no disassembly was observed.Backup device was available to complete the procedure.No significant delay and no complications with the patient were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The reported acufex pro-oval upbiter punch, used in treatment, has not been returned for evaluation.Without the reported product a visual or functional evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, the jaw broke during use but did not disassemble from the device.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive force placed on the device 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 for the reported lot, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.Further investigation is not warranted at this time.

• Brand Name: ACUFEX PRO-OVAL UPBITER PUNCH
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10220873
• Report Number: 1219602-2020-00968
• Device Sequence Number: 3270922
• Product Code: NBH
• UDI-Device Identifier: 03596010253057
• UDI-Public: 03596010253057
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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): 08/27/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 7207083
• Device Catalogue Number: 7207083
• Device Lot Number: 50843136
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/10/2020
• Supplement Date Received by Manufacturer: 08/13/2020
• Initial Report FDA Received Date: 07/01/2020
• Supplement Report FDA Received Date: 08/27/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention