MAUDE Adverse Event Report: INTEGRA YORK, PA INC. GRNY-FRMN SCS 7-1/4ST CER CERAMIC-SUPERCUT-TC COMB; M12 - PLASTIC SURGERY

Catalog Number PM-21SC716CTC

Device Problem Break (1069)

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

Event Date 04/19/2021

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

A physician reported that the tip of the scissors (pm-21sc716ctc) broke during a facelift procedure while cutting soft tissue.The broken tip was clearly visible at the start of dissection and was removed with a tissue forceps.All broken parts were recovered.There was no patient injury reported and delay in surgery is unknown.

Manufacturer Narrative

The returned pm-21sc716ctc scissors are in used condition with the tip of one blade 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: GRNY-FRMN SCS 7-1/4ST CER CERAMIC-SUPERCUT-TC COMB
• Type of Device: M12 - PLASTIC SURGERY
• Manufacturer (Section D): INTEGRA YORK, PA INC.; 589 davies drive; 589 davies drive; york PA
• MDR Report Key: 11838066
• MDR Text Key: 251715910
• Report Number: 2523190-2021-00092
• 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,health
• Type of Report: Initial,Followup
• Report Date: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PM-21SC716CTC
• Device Lot Number: BE2103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2021
• Date Manufacturer Received: 05/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1