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

Catalog Number 26-1221

Device Problem Failure to Auto Stop (2938)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 01/15/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).It has been reported that the device will be returned for evaluation.Upon receipt of the device or other relevant information, a follow-up report will be submitted.

Event Description

It was reported that two perforators did not stop and disengage.Further information was requested and the products will be returned for evaluation.

Manufacturer Narrative

Udi -- (b)(4).The device was received for evaluation.The perforator was visually inspected.The device was heavily soiled.The perforator was then functionally tested.A series of holes were 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.A review of similar complaints found one similar issue reported against this lot and product code combination; however, this complaint was not confirmed.Trends will be monitored for this and similar issues.

• Brand Name: CODMAN DISP PERFORATOR
• Type of Device: DRILLS, BURRS, TREPHINES & ACC.
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8318400
• MDR Text Key: 135494501
• Report Number: 1226348-2019-10085
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• PMA/PMN Number: K791101
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 01/17/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 26-1221
• Device Lot Number: J02U52
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2019
• Initial Date Manufacturer Received: 02/17/2019
• Initial Date FDA Received: 02/07/2019
• Supplement Dates Manufacturer Received: 03/05/2019
• Supplement Dates FDA Received: 03/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 22 YR