MAUDE Adverse Event Report: ARTHROCARE CORP. MGNUM PUNCH (3.2MM); ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	OM-9020
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Foreign zip code: (b)(6).
Event or Problem Description
It was reported that the t-handle broke from the magnum punch.No patient injury was reported.Back-up device was available.
Additional Manufacturer Narrative
The reported mgnum punch (3.2mm) device, intended for use in treatment, was not returned for evaluation.A relationship between the product and reported incident cannot be established as the product was not returned.Without the reported product a visual evaluation cannot be performed and customer¿s complaint cannot be confirmed.An exact root cause cannot be determined with confidence; however, factors unrelated to the manufacture or design of the device that could have contributed to the reported event include: (1) excessive force.(2) normal wear and tear.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: MGNUM PUNCH (3.2MM)
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 8307521
• Report Number: 3006524618-2019-00072
• Device Sequence Number: 14045912
• Product Code: LXH
• UDI-Device Identifier: 00817470005967
• UDI-Public: 00817470005967
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2019

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: OM-9020
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/10/2019
• Supplement Date Received by Manufacturer: 03/06/2019
• Initial Report FDA Received Date: 02/05/2019
• Supplement Report FDA Received Date: 03/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1