MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PCH SCSR STR; ACCESSORIES,ARTHROSCOPIC

Catalog Number 012036

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

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

Event Date 10/12/2017

Event Type  malfunction  

Event Description

It was reported that during procedure the jaw of the scissors punch broke off inside the patient.All pieces was able to be removed.No patient injuries reported.

Manufacturer Narrative

Device investigation narrative - one straight scissor punch was returned for evaluation.Visual assessment of the device confirmed the reported complaint.The tip/cutting edge of the shaft has broken off.Examination of the tip showed it is heavily damage.As reported the surgeon was using this device to cut suture.This devices intended design is for the cutting of soft tissue not suture.Further investigation is not required at this time.Device returned for evaluation device evaluated by the manufacturer evaluation codes updated c-(b)(4).

• Brand Name: PCH SCSR STR
• 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 ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 6959262
• MDR Text Key: 90168358
• Report Number: 1219602-2017-01311
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/03/2017

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: 012036
• Device Lot Number: 50244469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/12/2017
• Initial Date FDA Received: 10/18/2017
• Supplement Dates Manufacturer Received: 11/02/2017
• Supplement Dates FDA Received: 11/03/2017
• 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: N
• Patient Sequence Number: 1