MAUDE Adverse Event Report: AESCULAP AG ACCULAN 3TI REAMER ATTACHM.HUDSON/ZIMMER; LARGE BONE POWER SYSTEMS

Model Number GB656R

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 07/18/2019

Event Type  Injury  

Manufacturer Narrative

Investigation results: we did receive the device in decontaminated condition for investigation.The device has been provided disassembled.The screw which is screwed in into the collet has broken-off.The remaining part can be seen inside the case.The investigation has been carried-out by the aesculap technical service (ats).The device gb656r with the serial number (b)(4) was distributed in february 2019.According to our database, no repair/maintenance took place in the past.Optically, the device is in a good condition.The screw with the article number gb656205 has broken-off.Therefore the tool mount has fallen apart.There are several reasons for the breaking of the screw: it is possible that a too high tightening torque was applied when screwing in the screw (manufacturing related).It is possible that the screw was damaged due to a fall or impact damage (usage related).However, no clear signs of damages can be found on the device.

Event Description

It was reported that there was an issue with a acculan 3ti reamer.When milling the acetabulum, the milling cutter broke apart.Additional measures were taken as a result of the event.Additional antibiotics were necessary according to the current knowledge.Further queries are still pending.Additional information was not provided up to now.The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

(manufacturing evaluation was previously submitted.) b5 : due to a clarification, the report was reassessed and found to no longer require submission - no serious injury.Additional antibiotics was not necessary, there were no patient hazard.

• Brand Name: ACCULAN 3TI REAMER ATTACHM.HUDSON/ZIMMER
• Type of Device: LARGE BONE POWER SYSTEMS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8965718
• MDR Text Key: 156764970
• Report Number: 9610612-2019-00602
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GB656R
• Device Catalogue Number: GB656R
• Device Lot Number: 52484801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2019
• Date Manufacturer Received: 09/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR