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 Code	Tissue Damage (2104)
Date of Event	06/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It has been reported that the device will not be returned for evaluation.A lot number has been provided.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
As reported by the affiliate, a perforator failed to disengage at the dura mater, causing a cerebral contusion.The secure system leading to disengage of perforator has not been activate that leading to a cerebral contusion (without injury, hemorrhage or cerebral disintegration), no further intervention was needed.The drill bit has been removed and there was no vital risk for the patient.Microscopically, the brain has been damaged but the contusion is not found on the scan.The patient must have an mri soon.This was the first time the device was used.It was reported that the bone quality was normal and the device was help perpendicular to the bony surface during use.
Additional Manufacturer Narrative
Udi (b)(4).Additional information: complaint sample was not returned to codman; therefore, an evaluation of the device could not be performed.A review of manufacturing records found no anomalies.The cause(s) of the difficulty reported by the customer could not be determined.Complaint will be closed as 'no complaint sample returned to codman for evaluation'.If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this or similar complaints.At present, we consider this complaint to be closed.
Additional Manufacturer Narrative
Udi: (b)(4).The device was received for evaluation.The perforator was visually inspected and no anomalies were observed.The perforator was then functionally tested.A series of holes with drilled without issues.The device performed as intended.A review of manufacturing records found no discrepancies when released to stock.Based on 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: 7718438
• Report Number: 1226348-2018-10510
• Device Sequence Number: 11011991
• Product Code: HBF
• UDI-Device Identifier: 10886704005100
• UDI-Public: (01)10886704005100(10)HW3871
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K791101
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/28/2018

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: 03/31/2023
• Device Model Number: 26-1221
• Device Catalogue Number: 26-1221
• Device Lot Number: HW3871
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2019
• Initial Date Received by Manufacturer: 06/28/2018
• Supplement Date Received by Manufacturer: 09/26/2018; 02/06/2019
• Initial Report FDA Received Date: 07/25/2018
• Supplement Report FDA Received Date: 09/26/2018; 02/22/2019
• 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: Other
• Patient Age: 46 YR