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

Model Number	3722110
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	08/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3003249645-2022-00042
• Device Sequence Number: 20134582
• Product Code: JYO
• UDI-Device Identifier: 10381780082217
• UDI-Public: 10381780082217
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2022
• Supplement Date Received by Manufacturer: 11/23/2022
• Initial Report FDA Received Date: 08/30/2022
• Supplement Report FDA Received Date: 12/06/2022
• Date Device Manufactured: 01/01/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown