MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. FORCEPS P761-6 120MM CVD HALSTEAD; PFM11

Catalog Number P761-6

Device Problems Break (1069); Material Integrity Problem (2978)

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

Event Type  malfunction  

Manufacturer Narrative

Integra has completed their internal investigation on october 25, 2017.Results: evaluation of returned device; the forceps are broken at section change at hinge.The fragment were returned.A corroded area can be observed within the fracture zone.It suggests the presence of a crack prior to the breakage.A thorough observation of the breakage area did not reveal manufacturing or material defect.Dhr review; no non-conformity related to this issue for this lot.Complaints history; no adverse trend.Conclusion: considering that no material or manufacturing defect was found and that there are evidences of a crack prior to the breakage, the most probable cause of this rupture is the recurrence of impacts on the instrument during its use, which weakened the forceps arm and progressively led to the reported event.Moreover, the ifu provided with the device requires to: "check the condition of instruments before and after each case.Remove from use any incomplete or poorly operation instruments".

Event Description

It was reported that the jaw of the forceps broke.Product was in contact with the patient; however, no patient injury was reported and the event did not lead to surgical delay.

• Brand Name: FORCEPS P761-6 120MM CVD HALSTEAD
• Type of Device: PFM11
• Manufacturer (Section D): INTEGRA MICROFRANCE S.A.S.; le pavillon; le pavillon; saint aubin le monial 03160 ; FR 03160
• Manufacturer (Section G): INTEGRA MICROFRANCE S.A.S.; le pavillon; saint aubin le monial 03160 ; FR 03160
• Manufacturer Contact: sonia irizarry ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 7002338
• MDR Text Key: 92475731
• Report Number: 2523190-2017-00128
• Device Sequence Number: 1
• Product Code: GEN
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/17/2017

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: P761-6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/17/2017
• Initial Date FDA Received: 11/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1