MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD ADULT REUSABLE SKULL PIN; ACCESSORIES

Catalog Number A1047

Device Problem Unstable (1667)

Patient Problem Laceration(s) (1946)

Event Date 12/20/2019

Event Type  Injury  

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.Linked to mfg number:3004608878-2020-00086.

Event Description

2 of 2 reports.It was reported that the a1059 mayfield modified skull clamp when the sales representative visited the hospital, the mayfield¿s worked according to the instruction for use.One of the surgeons tested the placement by giving a little force to the mayfield after placement to check if there is flexibility due to not having contact with the skull bone.The a1047 skull pins was reported as being blunt.A patient has a wound of approximately 5 cm by 0.5 cm deep, head injury.The surgeon told the sales representative that the problem is probably due to a user mistake.Additional information received on (b)(6) 2020 stated that the date of surgery was (b)(6) 2019, that the patient was position prone (on the belly.) the incident occurred after the placement of the clamp, by repositioning.The patient fell out of the clamp and was caught by the surgeon.The surgery continued by stitching the wound of the patient.The skull clamp is replaced, and the surgery was continued normally.The delay in surgery is 10 minutes.Request for additional information has been sent.

Event Description

N/a.

Manufacturer Narrative

Device identifier #: (b)(4).The device was not returned for evaluation.The lot and serial numbers have not been provided, therefore the device history record review was not completed.The failure analysis and root cause determination was not completed due to the product has not returned.The complaint is unconfirmed.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)(4), director of regulatory programs, office of product evaluation and quality and (b)(4), assistant director, mdr team, office of product evaluation and quality on july 8-9, 2020 to report these issues regarding mdr reports.

• Brand Name: MAYFIELD ADULT REUSABLE SKULL PIN
• Type of Device: ACCESSORIES
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• MDR Report Key: 10277730
• MDR Text Key: 202715130
• Report Number: 3004608878-2020-00087
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: PRE-AMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 01/17/2020

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: A1047
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: A1059 SKULL CLAMP