MAUDE Adverse Event Report: INTEGRA YORK, PA INC. REYNOLDS SUPERCUT SCS 5 CVD TUNGSTEN CARBIDE; SCISSORS

Catalog Number P6845TC

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/17/2021

Event Type  malfunction  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

This is 2 of 2 reports for the 2nd patient on which the device was used and linked to mfg report number 2523190-2021-00070: a facility reported that during use on two different patients, the tip of the reynold scissors (product id p6845tc) broke on one side of two scissors.When the surgeon was dissecting tissue, the tip of both scissors broke in almost the exact same place of the jaw.No patient injury or delay in surgery was reported.

Event Description

N/a.

Manufacturer Narrative

The returned p6845tc scissors are in used condition with the tips broken off due to physical/environmental damage.The reported complaint is confirmed.No manufacturing, workmanship or material deficiency has been identified.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.

• Brand Name: REYNOLDS SUPERCUT SCS 5 CVD TUNGSTEN CARBIDE
• Type of Device: SCISSORS
• Manufacturer (Section D): INTEGRA YORK, PA INC.; 589 davies drive; 589 davies drive; york PA
• MDR Report Key: 11699275
• MDR Text Key: 246509559
• Report Number: 2523190-2021-00071
• Device Sequence Number: 1
• Product Code: LRW
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 05/28/2021

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: P6845TC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2021
• Initial Date Manufacturer Received: 03/23/2021
• Initial Date FDA Received: 04/21/2021
• Supplement Dates Manufacturer Received: 05/17/2021
• Supplement Dates FDA Received: 05/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1