MAUDE Adverse Event Report: KARL STORZ SE & CO. KG FINISH BARREL BURR; ORTHOPAEDIC BUR, REUSABLE

Model Number 28205GE

Device Problem Fracture (1260)

Patient Problem Laceration(s) (1946)

Event Date 05/25/2023

Event Type  Injury  

Event Description

It was reported that there was an issue with the product 28205ge (finish barrel burr).The distal head broke during use.According to the complaint description, the breakage of the device occured during a surgery on a bone spur.Procedure was not completed successfully.Medical diagnostical intervention was required.Surgical delay and prolongation of surgery were between 15 to 60 minutes.Adverse consequences due to failure were larger incision, greater tissue damage, longer wound healing, longer work loss.

Manufacturer Narrative

The suspected device was returned and evaluation is in progress.Once the evaluation is completed, a supplemental report will be made.The event is filed under internal karl storz complaint id: (b)(4).

Manufacturer Narrative

The complained product was received on 2023-07-05 and was therefore available for investigation.The investigation has been completed on 2023-09-21.The product consists of an inner shaft and outer shaft.Visual and microscopical examination revealed a breakage of the cutter on the inner shaft, as described by the customer.Slight damages (scratches, deformations) can be found at the distal tip of the outer shaft.These damages occured most likely partially after the breakage of the cutter.Additionally, run-in marks can be found on the mantle surface of the inner shaft.These run-in marks might indicate insufficient cooling.As described in the corresponding ifu 96156018d, the cutter must not be operated without flushing, as this can lead to overheating and abrasion on the running surfaces.The flushing also serves as a coolant and lubricant for the running surfaces of the cutter.If this fluid is missing, the error pattern described by the customer can occur.A speed that is set too high or too much pressure on the cutter can also cause this error pattern.The old age of the article may have contributed to this defect.The product history records have been checked for the available lot number and found to be according to the specification, valid at the time of production.Based on the available information and the results of the examination, the defect described by the customer can be confirmed.There is no indication for a material-, manufacturing- or design-related failure.The root cause of the reported issue is most likely usage related.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: FINISH BARREL BURR
• Type of Device: ORTHOPAEDIC BUR, REUSABLE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave.; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 17549064
• MDR Text Key: 321164385
• Report Number: 9610617-2023-00207
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 04048551110232
• UDI-Public: 4048551110232
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K030009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 28205GE
• Device Catalogue Number: 28205GE
• Device Lot Number: YS01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2017
• 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): Other; Required Intervention