MAUDE Adverse Event Report: AESCULAP AG TWIST DRILL D2.7MM L100/75MM AO-SHANK; LARGE BONE POWER SYSTEMS

Model Number GC316R

Device Problems Product Quality Problem (1506); Packaging Problem (3007)

Patient Problems Patient Problem/Medical Problem (2688); Unspecified Tissue Injury (4559)

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 twist drill.According to the complaint description surgical staff was seriously injured when removing the drill from the packaging.A temporary impairment occured.No persistent damage is known.Additional information was not provided nor available.The adverse event is filed under aag reference (b)(4).

Event Description

The adverse event is filed under aag reference (b)(4) ((b)(4)).

Manufacturer Narrative

Investigation results: visual investigation: the investigation has been carried-out optically.We did receive the drill inside the designated packaging.Several damages including a hole can be found on the front side of the packaging.The drill itself is in a good condition.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity x probability of occurrence) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigations results a capa is not necessary.

• Brand Name: TWIST DRILL D2.7MM L100/75MM AO-SHANK
• Type of Device: LARGE BONE POWER SYSTEMS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10212438
• MDR Text Key: 197568748
• Report Number: 9610612-2020-00248
• Device Sequence Number: 1
• Product Code: HTW
• 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: 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GC316R
• Device Catalogue Number: GC316R
• Device Lot Number: 4511208606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2020
• Date Manufacturer Received: 07/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other