MAUDE Adverse Event Report: AESCULAP AG TARGON SCREW DRIVER SW4.5 W/HOLD.DEVICE; TRAUMA SURGERY

Model Number KH325R

Device Problem Material Fragmentation (1261)

Patient Problems Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)

Event Date 07/28/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with a targon screw driver.According to the complaint description the end of the screwdriver (a cylindrical part) detached and was left in the patient.The part was identified by postoperative x-ray and removed 2 days later (2nd short anaesthesia for patient).A revision surgery was necessary to remove the broken part of the screwdriver.Additional information was not provided.Additional patient information is not available.The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation results: the device was investigated micrisopically and visually.No deviations can be found.Because the instruments exhibit no damages defects or missing parts, we assume that the cause of the problem described is a handling error.Most likely the surgeon screwed out the screw with the driver in "unlock"- position.In this position neither the screw on the hexagon nor the screw sleeve is secured against falling off from the tip.Therefore the failure is most probably user- related.

• Brand Name: TARGON SCREW DRIVER SW4.5 W/HOLD.DEVICE
• Type of Device: TRAUMA SURGERY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10460376
• MDR Text Key: 206961488
• Report Number: 9610612-2020-00427
• Device Sequence Number: 1
• Product Code: HWB
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: KH325R
• Device Catalogue Number: KH325R
• Device Lot Number: 52331290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2020
• Initial Date Manufacturer Received: 08/06/2020
• Initial Date FDA Received: 08/27/2020
• Supplement Dates Manufacturer Received: 09/03/2020
• Supplement Dates FDA Received: 09/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention