MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO TREPANE CODMAN; DRILLS, BURRS, TREPHINES & ACCESSORIES

Catalog Number 261221

Device Problem Failure to Auto Stop (2938)

Patient Problems Abrasion (1689); Blood Loss (2597)

Event Date 10/18/2018

Event Type  Injury  

Manufacturer Narrative

The device is available for return.A follow up report will be filed once the quality investigation is complete.

Event Description

It was reported that during a cranial procedure, the perforator bit did not stop.It was also reported that there was an unintentional durotomy which may have been due to drilling near a tumour which had adhered to the patient skull/dura.It was further reported that the patient required transfusion of two units of blood.It was also reported that there were no surgical delay and the procedure was completed successfully.

Event Description

It was reported that during a cranial procedure, the perforator bit did not stop.It was also reported that there was an unintentional durotomy which may have been due to drilling near a tumour which had adhered to the patient skull/dura.It was further reported that the patient required transfusion of two units of blood.It was also reported that there were no surgical delay and the procedure was completed successfully.

Manufacturer Narrative

Device evaluated by mfr: the perforator bit was not returned to stryker.The reported event, for perforator bit failure to disengage, was not confirmed as the perforator bit was not returned for evaluation.Without the perforator bit, the root cause cannot be determined.Perforator bit was not returned by customer.

Event Description

It was reported that during a cranial procedure, the perforator bit did not stop.It was also reported that there was an unintentional durotomy which may have been due to drilling near a tumour which had adhered to the patient skull/dura.It was further reported that the patient required transfusion of two units of blood.It was also reported that there were no surgical delay and the procedure was completed successfully.

Manufacturer Narrative

Device evaluated by mfr: catalog number corrected to codman perforator 26-1221.Upon receipt of the perforator bit in service by the tracking number, it was discovered the perforator bit used in the event was a codman perforator, 26-1221 lot# hy4354, and not a stryker bit.Notified codman and received an acknowledgement from the manufacturer.

• Brand Name: TREPANE CODMAN
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8073442
• MDR Text Key: 127231610
• Report Number: 0001811755-2018-02479
• Device Sequence Number: 1
• Product Code: HBF
• UDI-Device Identifier: 04546540716224
• UDI-Public: 04546540716224
• Combination Product (y/n): N
• PMA/PMN Number: K082010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 261221
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2019
• Initial Date Manufacturer Received: 10/19/2018
• Initial Date FDA Received: 11/15/2018
• Supplement Dates Manufacturer Received: 01/14/2019; 01/29/2019
• Supplement Dates FDA Received: 01/14/2019; 02/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 5400050000 S/N: (B)(4); 5400210020 S/N, (B)(4); 5400210050 S/N, (B)(4); 5400210060 S/N, (B)(4); 5407100000 S/N: (B)(4); 5407120470 S/N, (B)(4); 5407120472 S/N, (B)(4); 5407FA2000 S/N, (B)(4); 5407NFA8CM S/N, (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR