MAUDE Adverse Event Report: INTEGRA YORK, PA INC. CARB-BITE MAYO-HEGAR NH 7; CARDIOVASCULAR NEEDLE HOLDERS

Catalog Number 121140

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/19/2019

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A customer reported that on (b)(6) 2019, the operating room staff stated while using the 121140 carb-bite mayo-hegar nh 7, the ¿tungsten carbide insert came off the needle driver.Piece was retrieved and sent with needle driver to clinical engineering¿.Additional information received on 28oct2019 and 31oct2019 stated that there was patient contact, however, there was no patient injury or harm reported.There was no surgical delay.Both the device and the broken piece were saved.The device was being used in accordance with the information for use.The customer reported event will be voluntarily reported to the fda via medwatch.

Manufacturer Narrative

The device was not returned for evaluation.There is blackening at the break site indicating that this could had started as stress fracture and with continued cleaning it caused the instrument to break.This complaint is confirmed; damaged/ worn.The root cause has not been identified as a workmanship or material deficiency.

Event Description

N/a.

Manufacturer Narrative

The product was returned for evaluation.The returned needle holder was used with a portion of the male jaw insert was broken.No preventive maintenance/repair markings are present.The finger ring coating is faded with brown corrosion stains over the body of the instrument.The inserts are stained.No manufacturing, workmanship, or material deficiency has been identified.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 (b)(4) 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)(4) office of product evaluation and quality on july 8-9, 2020 to report these issues regarding mdr reports.

• Brand Name: CARB-BITE MAYO-HEGAR NH 7
• Type of Device: CARDIOVASCULAR NEEDLE HOLDERS
• Manufacturer (Section D): INTEGRA YORK, PA INC.; 589 davies drive; 589 davies drive; york PA 17402
• MDR Report Key: 9310227
• MDR Text Key: 202043582
• Report Number: 2523190-2019-00137
• Device Sequence Number: 1
• Product Code: DWS
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 121140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2019
• Date Manufacturer Received: 12/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1