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	07/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It has been reported that the device will be returned for evaluation.Upon completion of the investigation.
Event or Problem Description
As reported by the sales rep, a perforator fell apart after use.There were no reports of delays or patient harm.
Additional Manufacturer Narrative
The device has been returned for evaluation.Upon completion of the investigation, a follow-up report will be submitted.
Additional Manufacturer Narrative
The device was returned for evaluation.The perforator was visually inspected.The unit was received disassembled and showed heavy damage on both the inner and outer drill that is not related to the manufacturing process.It was also missing the drive pin.Functional testing could not be performed due to the condition of the device as received.The unit was re-sleeved and passed functional testing.A review of manufacturing records found no anomalies during the manufacturing process.Based on the investigation, it was confirmed that the device had become disassembled.However, it is not possible to determine at what point and what conditions caused the damage that was observed.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: 7743055
• Report Number: 1226348-2018-10552
• Device Sequence Number: 11160179
• Product Code: HBF
• UDI-Device Identifier: 10886704005100
• UDI-Public: (01)10886704005100(10)HY0707
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K791101
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: 26-1221
• Device Catalogue Number: 26-1221
• Device Lot Number: HY0707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2018
• Initial Date Received by Manufacturer: 07/10/2018
• Supplement Date Received by Manufacturer: 08/23/2018; 10/06/2018
• Initial Report FDA Received Date: 08/02/2018
• Supplement Report FDA Received Date: 08/24/2018; 10/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1