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	10/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Foreign zip code: (b)(6).
Event or Problem Description
It was reported that during a procedure, when tapping underneath the t-bar there was a crack and the top came off from the punch.The punch was removed.A backup device was available to complete the procedure with no delay or patient injuries.
Additional Manufacturer Narrative
The reported magnum 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.From the information provided, ¿tapping underneath the t-bar there was a crack and the top came off from the punch.¿ an exact root cause cannot be determined without evaluation of the device; however, factors unrelated to the manufacture or design of the device that could have contributed to the reported event include: excessive force.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.
Additional Manufacturer Narrative
The returned instrument, intended for use in treatment, was returned as an mdr for evaluation.There was a relationship found between the returned instrument and the reported incident.Visual inspection shows an instrument with a detached handle and 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.

• 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: 8099961
• Report Number: 3006524618-2018-00611
• Device Sequence Number: 2165255
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/25/2019

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
• Device Lot Number: TBC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2019
• Initial Date Received by Manufacturer: 11/06/2018
• Supplement Date Received by Manufacturer: 01/03/2019; 02/22/2019
• Initial Report FDA Received Date: 11/23/2018
• Supplement Report FDA Received Date: 01/04/2019; 02/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1