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

Catalog Number 26-1221

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 12/11/2018

Event Type  Injury  

Manufacturer Narrative

Udi -- (b)(4).Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

As reported by the affiliate, during surgery a perforator became stuck in the bone.When forceps were used to remove it, it separated, with the blade remaining in the bone.It was removed and another perforator was used to complete the procedure.

Manufacturer Narrative

The device has been returned for evaluation.Upon completion of the investigation, a follow-up report will be submitted.

Manufacturer Narrative

Udi: (b)(4).The sample was received for evaluation.The sample was visually inspected, and the unit was significantly soiled.It was noted that the sample was no longer assembled.The unit was missing its spring.The test could not be executed in the as-received condition.Following re-sleeving and the additional of a spring, the test was performed on the unit and was found to perform as intended.Following re-sleeving and the addition of a spring, a series of five holes was performed and the unit was found to perform as intended.A review of manufacturing records found no anomalies during the manufacturing process.Based on the results of the investigation, the reported issue could not be confirmed.

• Brand Name: CODMAN DISPOSABLE PERFORATORNI
• Type of Device: DRILLS, BURRS, TREPHINES & ACC.
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8214337
• MDR Text Key: 131984415
• Report Number: 1226348-2019-10008
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• PMA/PMN Number: K791101I
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2019
• 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: J05X68
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2019
• Date Manufacturer Received: 03/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention