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)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It has been reported that the device will be returned for evaluation.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, perforating the dura.
Additional Manufacturer Narrative
The device was returned for evaluation.The perforator was visually inspected.The unit was received with a torn product label and damaged blue sleeve.All damage was deemed to be unrelated to the manufacturing process.Functional testing was then performed.A series of holes were drilled per the test method.No issues were found.The device functioned as intended.A review of manufacturing records could not be reviewed, as no lot information was provided.Based on the results of the investigation, the reported issue could not be confirmed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
Additional Manufacturer Narrative
The device has been returned for evaluation.Upon completion of the investigation, a follow-up report will be submitted.

• 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: 7731306
• Report Number: 1226348-2018-10518
• Device Sequence Number: 2541601
• Product Code: HBF
• UDI-Device Identifier: 10886704005100
• UDI-Public: (01)10886704005100
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/02/2018

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 Model Number: 26-1221
• Device Catalogue Number: 26-1221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2018
• Initial Date Received by Manufacturer: 07/02/2018
• Supplement Date Received by Manufacturer: 07/27/2018; 09/28/2018
• Initial Report FDA Received Date: 07/30/2018
• Supplement Report FDA Received Date: 08/22/2018; 10/04/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention