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

Catalog Number 26-1221

Device Problem Device Operational Issue (2914)

Patient Problem No Information (3190)

Event Date 04/19/2016

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).Upon completion of the investigation a follow up report will be filed.

Event Description

A disposable perforator was sent to codman from stryker instruments, (b)(4) with the following event details: "the perforator came off from the perforator chuck when the surgeon tried to pull the perforator out from the patient, then the perforator remained on the patient.Then our service staff tested it using demo units.Then he found that using the older chuck, s/n (b)(4) did not replicate the same failure but the newer one s/n (b)(4) could replicate the same failure, then he checked the perforator chucks and found the position of the ball retainer was different.It is likely the design change was done in 2008 by checking the drawing.Update 12-may-2016: the perforator bit was not retained - there was no adverse consequences for the patient in this event.".

Manufacturer Narrative

(b)(4).Upon completion of the investigation it was noted that the customer's complaint was not verified.The customers¿ perforator met functional test acceptance requirements; proper engagement and disengagement was achieved with every drill hole, and there was no erratic or poor cutting action.The device history records (perforator assembly) show all tests and inspections, including a drilling test on each perforator, met specification requirements.Based on the results of this investigation no further action is required.Trends will be monitored for this and similar complaints.At the present time this complaint is closed.

• Brand Name: CODMAN DISPOSABLE PERFORATOR
• Type of Device: DRILLS, BURRS, TREPHINES & ACC.
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; new bedford industrial park; new bedford MA 02745
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 6013532
• MDR Text Key: 56980988
• Report Number: 1226348-2016-10716
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K791101
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup

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
• Device Operator: Health Professional
• Device Catalogue Number: 26-1221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/16/2016
• Initial Date FDA Received: 10/10/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1