MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD RADIOLUCENT SKULL PINS; RADIOLUCENT PRODUCT ACCESSORIES

Catalog Number A2020

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/10/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not yet received by the manufacturer for evaluation.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A medwatch form with uf/importer report #3933020000-2020-8002 was received on (b)(6) 2020 with the following information: on (b)(6) 2020, during the removal of the a2020 mayfield radiolucent skull pins, the neurosurgical fellow noted retained parts left in the left sided pin site.The fellow removed the retained particles and pins.They were placed into a biohazard bag.There was no harm to patient reported.Additional information received on 14feb2020 and 18feb2020 indicating that the fragments were removed by using the monteris head holder and pins were tightened.It was mentioned that they heard the frame "give".The product was reported to be in contact with fluids, but not with a hazardous agent.There was no known revision or medical intervention done and/or delay in surgery.

Manufacturer Narrative

Device identifier # (b)(4).The device was returned for evaluation.The device history record (dhr) was reviewed with no abnormalities related to the reported failure.The device passed all required inspection points with no associated mrr¿s, variances or rework.The complaint was confirmed from the visual evaluation of the returned product.Two skull pins was found in the unit with the tip damaged.The observed condition is consistent with; improper insertion of the skull pins into the skull clamp (when the skull pin is not fully seated on the skull clamp) and the improper placement of the skull clamp during use and the use of non-compatible skull clamps.The definite root cause cannot be reliable determined.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.

Event Description

N/a.

• Brand Name: MAYFIELD RADIOLUCENT SKULL PINS
• Type of Device: RADIOLUCENT PRODUCT ACCESSORIES
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• MDR Report Key: 10278090
• MDR Text Key: 203498020
• Report Number: 3004608878-2020-00106
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: K071458
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/05/2020

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: A2020
• Device Lot Number: W1808188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2020
• Date Manufacturer Received: 03/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MONTERIS HEAD HOLDER
• Patient Age: 19 YR
• Patient Weight: 80