MAUDE Adverse Event Report: KARL STORZ SE & CO. KG MICROFRACTURE CHISEL, 90

Model Number 28140CF

Device Problem Fracture (1260)

Patient Problem Tissue Damage (2104)

Event Date 01/29/2020

Event Type  malfunction  

Manufacturer Narrative

Per the evaluation findings: the tip was found to be broken, the broken off tip was not returned.The remaining tip was found to be bent.The distal end of the instrument shows hammer strokes.Therefore the root cause most likely is too high force application by hammer strokes.No indication of a material or manufacturing related issue was found during the investigation.

Event Description

As per a vigilance report received from the factory in (b)(4), when the mandrel for the pridie drill hole was placed, the hardened tip broke off immediately.No hammer used.The tip had to be removed through an extra skin incision.

• Brand Name: MICROFRACTURE CHISEL, 90
• Type of Device: CHISEL
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer Contact: susie chen ; 2151 e. grand avenue; el segundo, ca ; 2188201
• MDR Report Key: 9709134
• MDR Text Key: 199988287
• Report Number: 9610617-2020-00023
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 04048551134092
• UDI-Public: 4048551134092
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 01/31/2020

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: 28140CF
• Device Catalogue Number: 28140CF
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/31/2020
• Initial Date FDA Received: 02/13/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/15/2018
• 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 Outcome(s): Required Intervention