MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. NEEDLE HOLDER CEV500T5 DIA 5MM TUNGSTEN; PFM16

Catalog Number CEV500T5

Device Problem Fracture (1260)

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

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 facility reported that during a laparoscopic surgery for a bilateral inguinal hernia, the articulated jaw of the needle holder broke in patient's abdomen.The broken piece was retrieved from the patient¿s abdomen and another needle holder was used to finish the procedure.There was no reported consequence for the patient and the surgery delay was stated to be less than 30 minutes.

Event Description

N/a.

Manufacturer Narrative

Product or objective evidence was returned for evaluation.The mobile jaw was broken.The fragment was not returned.There was a corroded area within the fracture zone.It suggests the presence of a crack prior to the breakage.No manufacturing or material defect was detected.Dhr for lot no.3493988 was reviewed and no anomalies that could be associated with the complaint were observed.The evaluation verified the complaint as valid.The most probable cause of this rupture was the recurrence of impacts on the instrument during its use or its reprocessing, which weakened the jaw and progressively led to the reported event.Moreover, the instructions for use (ifu) provided with the device requires to: "inspect components for any damage.If damage is observed, do not use the instrument until it is repaired." between 05nov2019 and 30jun2020, approximately 2,200 mdrs submitted electronically by integra lifesciences via trackwise, integra's complaint handling system, were not received by cdrh due to a computer system issue.Within this time period, an error with integra's middleware, which facilitates communications between trackwise and the fda system, caused the complaint records to close and indicate we had received an acknowledgement 3 from the fda when we had not.Integra interpreted the acknowledgement as a successful submission; however, subsequent investigation revealed the acknowledgement 3 received was from our middleware and not from the fda (these acknowledgements have been retained as part of the documentation of the mdr).The malfunction was related to the relocation of the trackwise application to a new data center during the transition of integra's corporate headquarters from plainsboro, nj to princeton, nj.Previously, integra had been successfully receiving acknowledgements 1, 2, and 3 from the fda, and our records reflect these acknowledgements, including the date and time stamps.Capa pr 229048 and nc 20-011 have been opened by integra to further investigate the nonconformance and develop a corrective action plan.The middleware error has been corrected, and integra has filed mdrs since the correction and verified that the appropriate acknowledgements have been received from the fda.Integra is resubmitting all impacted mdr reports for the time period 05nov2019 through 30jun2020.Integra lifesciences contacted (b)(6) , director of regulatory programs, office of product evaluation and quality and (b)(6) , assistant director, mdr team, office of product evaluation and quality on july 8-9, 2020 to report these issues regarding mdr reports.

• Brand Name: NEEDLE HOLDER CEV500T5 DIA 5MM TUNGSTEN
• Type of Device: PFM16
• Manufacturer (Section D): INTEGRA MICROFRANCE S.A.S.; le pavillon; le pavillon; saint aubin le monial 03160 ; FR 03160
• MDR Report Key: 10280453
• MDR Text Key: 203514076
• Report Number: 2523190-2020-00051
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• PMA/PMN Number: K080257
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CEV500T5
• Device Lot Number: 3493988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2020
• Date Manufacturer Received: 05/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1