MAUDE Adverse Event Report: DERMA SCIENCES, INC. CAST REMOVAL SAW; TCC OTHER

Catalog Number TCC2SAW

Device Problem Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/15/2018

Event Type  malfunction  

Manufacturer Narrative

The device was not yet returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

It was reported by the customer that on (b)(6) 2018, when cutting the cast off of a patient, the tcc2saw cast removal saw started to smoke and then stopped working.The customer borrowed a cast saw from an orthopedic doctor office nearby to complete the procedure.No patient injury were reported.Additional information was already requested.

Manufacturer Narrative

The device was not returned to the manufacturer for evaluation.However, the vendor was notified on the complaint and a thorough investigation was done based on the current inventory.25% of the inventory were tested and no issues were noticed.All released without quality issues.Based on the evaluation conducted, the root cause might have been due to faulty barring.This was considered as an isolated case.

• Brand Name: CAST REMOVAL SAW
• Type of Device: TCC OTHER
• Manufacturer (Section D): DERMA SCIENCES, INC.; 104 shorting road; 104 shorting road; toronto, ontario M1S 3 S4; CA M1S 3S4
• Manufacturer (Section G): DERMA SCIENCES, INC.; 104 shorting road; toronto, ontario M1S 3 S4; CA M1S 3S4
• Manufacturer Contact: vivian nelson ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 7406543
• MDR Text Key: 105255925
• Report Number: 9680091-2018-00014
• Device Sequence Number: 1
• Product Code: LGH
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: TCC2SAW
• Device Lot Number: 35160
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 60 YR