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
(b)(6).
Event or Problem Description
It was reported that during procedure, t-handle from magnum punch broke inside the patient.The surgeon was holding the instrument when it broke so it was removed by hand.The procedure was successfully completed without delay using a back-up device.No patient injury or other complications were reported.
Additional Manufacturer Narrative
There was a relationship found between the returned instrument and the reported incident.Visual inspection shows an instrument with a detached t handle respective a loose rod.No manufacturing anomalies could be identified on the returned instrument.The returned instrument is a single used device and could not be functional tested.The complaint was verified and the root cause could not be determined due to a mechanical component failure.There were no indications 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: 8256271
• Report Number: 3006524618-2019-00021
• Device Sequence Number: 2056892
• 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): 03/15/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019
• Initial Date Received by Manufacturer: 01/10/2019
• Supplement Date Received by Manufacturer: 03/15/2019
• Initial Report FDA Received Date: 01/17/2019
• Supplement Report FDA Received Date: 03/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1