MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR KIT CONTAINING CC1.P1 AND THE IP2 INTRODUCER; LICOX BOLTS CATHETERS & KITS

Catalog Number	IP2P
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	01/26/2024
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
This is 2 of 2 reports linked to mfg report number 1722447-2024-00004: a facility reported that during use of the hand drill and the licox drill bit (ip2p), 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.
Additional Manufacturer Narrative
Additional information received as follows: correction name of hospital: (b)(6).Patient 39 years old, 94kg.
Additional Manufacturer Narrative
The kit containing cc1.P1 and the ip2 introducer (ip2p) was not returned for evaluation after three good faith attempts (gfes) were made.Lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.The root cause could not be determined.However, the probable root cause for the reported complaint could be due to human misuse as the customer was going off label for the use of the ins030 hand drill.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
Event or Problem Description
N/a.

• Brand Name: KIT CONTAINING CC1.P1 AND THE IP2 INTRODUCER
• Common Device Name: LICOX BOLTS CATHETERS & KITS
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• Manufacturer (Section G): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; ch-2400; le locle ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 18764504
• Report Number: 3013886523-2024-00050
• Device Sequence Number: 7739323
• Product Code: GWM
• UDI-Device Identifier: 10381780250333
• UDI-Public: 10381780250333
• Combination Product (Y/N): N
• PMA/510(K) Number: K040235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: IP2P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2024
• Supplement Date Received by Manufacturer: 02/28/2024; 04/23/2024
• Initial Report FDA Received Date: 02/22/2024
• Supplement Report FDA Received Date: 03/11/2024; 05/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Sex: Unknown
• Patient Weight: 94 KG