MAUDE Adverse Event Report: SPIGGLE & THEIS MEDIZINTECHNIK GMBH / JEDMED ROSEN ROUND KNIFE WEAPON MICRO EAR INSTRUMENT; KNIFE, EAR

Model Number 10-610-25

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/27/2019

Event Type  malfunction  

Event Description

Instrument (weapon micro ear instrument) broke while surgeon was using it during procedure (r type 3 tympanoplasty with cartilage graft).The end of the instrument snapped off and broke in to two pieces.The piece that broke off was retrieved from the wound.No harm evident, instrument was retained for review.The item is a 16cm long rosen round knife #10-610-25.The smallest diameter at 2mm is what broke off in the pt.The opposite end of this instrument (handle) is 5mm in diameter.Fda safety report id# (b)(4).

• Brand Name: ROSEN ROUND KNIFE WEAPON MICRO EAR INSTRUMENT
• Type of Device: KNIFE, EAR
• Manufacturer (Section D): SPIGGLE & THEIS MEDIZINTECHNIK GMBH / JEDMED
• MDR Report Key: 9166186
• MDR Text Key: 161666213
• Report Number: MW5090245
• Device Sequence Number: 1
• Product Code: JYO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10-610-25
• Device Lot Number: 045/04-19
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 69