MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN DISPOSABLE PERFORATOR; DRILLS, BURRS, TREPHINES & ACC.

Model Number	26-1221
Medical Device Problem Code	Failure to Auto Stop (2938)
Health Effect - Clinical Codes	Tissue Damage (2104); Blood Loss (2597)
Date of Event	06/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been returned for evaluation.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
As reported by the sales rep, a perforator failed to disengage.The superior sagittal sinus was breached and the patient had a 700-800 cc blood loss over 3-5 minutes.As a result, the patient suffered 2 small strokes.
Additional Manufacturer Narrative
Udi : (b)(4).The device was returned for evaluation.The perforator was visually inspected.No anomalies were observed, other than the unit being soiled and the product label being torn.Functional testing was the performed per the test method.A series of holes were drilled without issue.A review of manufacturing issues was performed and no anomalies were found.Based on the results of the investigation, the reported issue could not be confirmed.The device functioned as intended.Trends will be monitored for this and similar issues.At present we consider this complaint to be closed.

• Brand Name: CODMAN DISPOSABLE PERFORATOR
• Common Device Name: DRILLS, BURRS, TREPHINES & ACC.
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham 02767
• MDR Report Key: 7743687
• Report Number: 1226348-2018-10555
• Device Sequence Number: 1404809
• Product Code: HBF
• UDI-Device Identifier: 10886704005100
• UDI-Public: (01)10886704005100(10)HR5903
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K791101
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: 26-1221
• Device Catalogue Number: 26-1221
• Device Lot Number: HR5903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2018
• Initial Date Received by Manufacturer: 07/11/2018
• Supplement Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 08/02/2018
• Supplement Report FDA Received Date: 09/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention