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

Model Number	26-1221
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/02/2018
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
It was reported that during use the perforator broke apart.When the surgeon tried to make the hole, the sealed part got caught, and it peeled apart.Those pieces scattered into the skin were removed.There was no reported adverse events for the patient.No further information was provided by hospital.The product will be returned to your site.
Additional Manufacturer Narrative
Udi : (b)(4).The device was returned for evaluation.The perforator was visually inspected.No anomalies were found, other than slight wear on the product label.Functional testing was then performed per the test method.A series of holes were drilled without issue.A review of manufacturing records found no anomalies.Based on the investigation, the reported issue could not be confirmed.The device functioned as intended.Trends will be monitored for this and similar complaints.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: 7739942
• Report Number: 1226348-2018-10546
• Device Sequence Number: 756900
• Product Code: HBF
• UDI-Device Identifier: 10886704005100
• UDI-Public: (01)10886704005100(10)HR9182
• 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
• Report Date (Section B): 07/10/2018

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: 02/28/2023
• Device Model Number: 26-1221
• Device Catalogue Number: 26-1221
• Device Lot Number: HR9182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2018
• Initial Date Received by Manufacturer: 07/10/2018
• Supplement Date Received by Manufacturer: 09/12/2018
• Initial Report FDA Received Date: 08/01/2018
• Supplement Report FDA Received Date: 09/28/2018
• 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