MAUDE Adverse Event Report: RAYNHAM CODMAN DISPOS PERFORATOR; DISPOSABLE PERFORATORS

Model Number 261221

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/13/2022

Event Type  malfunction  

Event Description

A facility reported a that during an unspecified procedure, the disposable perforator (id 261221) was being used to make a bone hole, but became buried in the bone and could not come out of the bone.The physician tried to pull it out, and the device was disassembled.It is unknown if the perforator clicked in place on the drill.It is also unknown if the recommended spring tests were performed between each burr hole.It is unknown if device failure led to surgical delay; however, there was no patient injury.

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Manufacturer Narrative

The disposable perforator (id 261221) was returned for evaluation.Device history record (dhr) - there is an indication that the production process may have contributed to this complaint.All test results passed procedural specifications, however due to (b)(6) units being scrapped at the welding step in production, it is possible that the process could have contributed to the complaint condition.Failure analysis - the perforator unit was inspected using the unaided eye: the unit was received disassembled and had a shallow weld on the blue sleeve.Ifu testing procedure was performed with no observed anomalies after being reassembled with the original parts.Functional testing was performed using the same protocol it underwent at finished goods testing prior to release: the unit was found to perform as intended and fulfilled the acceptance criteria after being reassembled.In the failure analysis that was performed, the returned unit was found to work as intended, and met all acceptance criteria, however because there were 17 units scrapped during the production process during the welding step, the production process could have attributed to the complaint condition.The complaint could be verified through failure analysis.The complaint was confirmed in the complaint investigation.The failure analyst was able to test the unit and while it passed functional testing and met the requirements, the dhr review revealed that 17 out of 80 units were scrapped for welding issues during production.Since the production issue is related to the complaint condition, it is possible that the manufacturing process could have contributed to the complaint condition.Currently the complaint issue does not represent an adverse trend, however the issue will continue to be monitored and trended through the complaint evaluation process.The risk remains acceptable per the risk analysis.

Event Description

N/a.

• Brand Name: CODMAN DISPOS PERFORATOR
• Type of Device: DISPOSABLE PERFORATORS
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA
• Manufacturer (Section G): RAYNHAM; 325 paramount drive; raynham MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 14320220
• MDR Text Key: 292988649
• Report Number: 3014334038-2022-00085
• Device Sequence Number: 1
• Product Code: HBF
• UDI-Device Identifier: 10381780513599
• UDI-Public: 10381780513599
• 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,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/02/2022

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 Model Number: 261221
• Device Catalogue Number: 261221
• Device Lot Number: 6040484
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2022
• Initial Date FDA Received: 05/07/2022
• Supplement Dates Manufacturer Received: 07/18/2022
• Supplement Dates FDA Received: 08/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1