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

Catalog Number INS030

Device Problem Device-Device Incompatibility (2919)

Patient Problem Hematoma (1884)

Event Date 01/26/2024

Event Type  Injury  

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

This is 1 of 2 reports linked to mfg report number 3013886523-2024-00050: a facility reported that during use of the hand drill (ins030) and the ip2p licox drill bit, it was impossible to put the licox drill bit properly in the hand drill, so the patient had a subdural hematoma.The hand drill chuck does not open enough to put the ip2p drill bit inside, and it seems to be a compatibility issue.Additional information was later received as follows: "during an implantation of ptio2 in intensive care, the ip2p substitution kit was used.The drill bit contained in the ip2p kit was used with the integra hand drill ins030.The drill bit was loose and became unfit from the hand drill in the patient's skull.The resuscitator had to remove the wick by hand.Bone splinters were identified on the ct scan as well as an intra-parenchymal hematoma on the side, linked to the introduction of the drill bit.".The incident led to extension of the duration of hospitalization and reinforced monitoring.

Manufacturer Narrative

The hand drill (b)(6) was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the "actual" device could not be performed, and device history record (dhr) could not be reviewed.Failure analysis - the ins030 drill is authorized for use with the 4 integra brand drill bits listed in the ifu (instructions for use).The unauthorized ip2 drill bit is not among those 4.Although the exact hand drill and drill bit used in the procedure that led to this complaint were not received by this site, a drill bit of similar advertised dimensions to the ip2 drill bit was paired with one of the ins030 hand drills for examination.It was confirmed that these are not compatible and will not remain steady or safe for use on a patient.Therefore, the drill chuck is not compatible with the bit used by the customer.Root cause - the root cause identified is "off-label customer use." no adverse trend has been identified; as such, no corrective action is being initiated at this time.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Event Description

N/a.

Manufacturer Narrative

Additional information received as follows: correction name of hospital: (b)(6).Patient 39 years old, 94kg.

Event Description

N/a.

• 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: 18764503
• MDR Text Key: 336053830
• Report Number: 1722447-2024-00004
• 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,Health Professional,User Facility
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: INS030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2024
• 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
• Patient Age: 39 YR
• Patient Weight: 94 KG