MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PCH,BSKT,SCP,UPBTR,1.5MM; ACCESSORIES,ARTHROSCOPIC

Catalog Number 012020

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

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

Event Date 09/25/2015

Event Type  malfunction  

Manufacturer Narrative

Visual assessment confirmed the reported complaint of breakage.The lower jaw has broken from the shaft and was not returned for examination.The handle and shaft have been highly polished.All markings (lot, part, etc) have been removed by the aforementioned polishing.Finger loop of handle has been chemically etched with ¿cf 12/15¿.The device has been repaired in a manner inconsistent with current smith & nephew practices, it cannot be determined if the repair contributed to the devices failure without the return of the lower jaw.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 a procedure the jaw broke off from the device while inside the surgical site.The broken piece was removed from the joint with graspers.There were no patient complications reported as a result of this event.

• Brand Name: PCH,BSKT,SCP,UPBTR,1.5MM
• 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: 5975971
• MDR Text Key: 55914833
• Report Number: 1219602-2016-01090
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/28/2015

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: 012020
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2015
• Initial Date Manufacturer Received: 09/28/2015
• Initial Date FDA Received: 09/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1