MAUDE Adverse Event Report: INTEGRA PAIN MANAGEMENT HAND DRILL - STERILE; N/A

Catalog Number INS030

Device Problem Component or Accessory Incompatibility (2897)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

A facility reported that there was an issue with the hand drill (ins030) during the implantation of a licox sensor: the licox drill bit could not be inserted in the jaws of the hand drill.Also, when the hand drill received a drill bit drill bit contained in the licox kit (ip2p), the mandril (chuck) of the hand drill is not adapting: the jaws become eccentric, and the drill bit cannot be inserted more than 4mm.The use of the drill bit was very unstable: the jaw was loose during the procedure and the drill bit became unhooked.There was no issue with the licox sensor.Additional information received indicates the following: ¿several incidents occurred with ins030 lot 7253130 with different outcomes: increase of time superior to 30min, implant failure.Mandril broke.Trepan holes are not "clean" and presence of intracranial bone fragments.¿ we are awaiting further information to identify if these are different events or events during the same procedure and patient.

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

N/a.

Manufacturer Narrative

The hand drill (ins030) was not returned for evaluation; however, investigation of retained chuck was performed as follows: device history record (dhr): the dhr was reviewed and no anomalies that could be associated with the complaint incident was observed.Failure analysis: although product was not returned, a chuck of the new design and a drill bit of the dimensions described in the complaint were sourced and examined on site.It was confirmed that a round drill bit of the dimensions given cannot be assembled in a stable configuration with the hand drill chuck design.The drill chucks meet all contract requirements per the agreements between integra and the supplier, but this off label third-party product does not allow for reliably safe operation of the ins030 drill with the ip2 drill bit.This tolerance stack up incompatibility was checked and verified on site with an ins030 drill and drill bit of the same diameter as the ip2 drill bit.The hand drill is approved for use with any of the 4 integra drill bits referenced in the ifus.The drill bit used in the complaint is not one of these 4 drill bits, nor does it have equivalent dimensions.The ip2 drill bit is not authorized for use with the ins030.Root cause: based on the available information and the retained chuck results, a round third-party drill bit of the dimensions given for the ip2 drill bit cannot allow for reliably safe operation of the ins030 drill.This drill bit is not approved for use with this hand drill.The hand drill is approved for use with any of the 4 integra drill bits referenced in the ifus.The drill bit used in the complaint is not one of these 4 drill bits, nor does it have equivalent dimensions.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: HAND DRILL - STERILE
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA PAIN MANAGEMENT; 3395 west 1820 south; 3395 west 1820 south; salt lake city UT
• Manufacturer (Section G): INTEGRA PAIN MANAGEMENT; 3395 west 1820 south; salt lake city UT
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 18508054
• MDR Text Key: 333459907
• Report Number: 1722447-2024-00001
• Device Sequence Number: 1
• Product Code: HBG
• Combination Product (y/n): N
• PMA/PMN Number: K961113
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: INS030
• Device Lot Number: 7253130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1