MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. KNIFE 3722110 SICKLE; PFM11

Model Number 3722110

Device Problem Packaging Problem (3007)

Patient Problem Laceration(s) (1946)

Event Date 08/05/2022

Event Type  Injury  

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 facility reported that the customer was cut by the sickle knife (3722110) when opening the box.It was reported the instrument was not in any packaging; there was no protective covering or bubble wrap.There was no patient involvement; thus, no patient injury or surgical delay was reported.

Manufacturer Narrative

The suspected sickle knife (3722110) was not returned for evaluation after three good faith attempts (gfes) were made.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies related to the reported complaint were found.A definitive root cause of the reported issue could not be determined.This complaint may be the result of the product not being packaged in a protective plastic case.The product drawing did not specify that the product should be packaged in a plastic case until july-2019 and this reported product lot indicates manufacture date of january 2019.Inspection of pre-2020 lots was initiated for this issue at the local distribution center and were discarded.

• Brand Name: KNIFE 3722110 SICKLE
• 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: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 15324608
• MDR Text Key: 298947688
• Report Number: 3003249645-2022-00042
• Device Sequence Number: 1
• Product Code: JYO
• UDI-Device Identifier: 10381780082217
• UDI-Public: 10381780082217
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 3722110
• Device Catalogue Number: 3722110
• Device Lot Number: AZ1901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/23/2022
• Date Device Manufactured: 01/01/2019
• 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