MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RAPTOR JR.,PUNCH; ACCESSORIES,ARTHROSCOPIC

Catalog Number 014843

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/27/2015

Event Type  malfunction  

Manufacturer Narrative

Visual assessment confirmed the reported breakage.Upper jaw has broken where it transitions from cutting surface to lug area.A small portion of the jaw (lug) remains attached to the shaft.Break area shows no material voids.Dimensional inspection of the device found it met print specifications.As reported surgeon was cutting bone with the device.This device was designed for the cutting of soft tissue not bone.No root cause related to the manufacturing process can be established.No further investigation is warranted at this time.

Event Description

It was reported that during an ankle arthroscopy using a raptor jr.Punch, the upper tooth/jaw broke off during procedure while biting bone.It snapped off in the patient but was able to be retrieved.A competitor's device was used to compete the procedure.There were no patient complications reported as a result of this event.

• Brand Name: RAPTOR JR.,PUNCH
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: jim gonzales ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 5975312
• MDR Text Key: 55899216
• Report Number: 1219602-2016-01004
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/28/2015

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
• Device Operator: Health Professional
• Device Catalogue Number: 014843
• Device Lot Number: 50523955
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2015
• Initial Date Manufacturer Received: 01/28/2015
• Initial Date FDA Received: 09/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1