MAUDE Adverse Event Report: AESCULAP AG DISP.SAW BLADE RAPID ACTION 90/23/1.47MM; LARGE BONE POWER SYSTEMS

Model Number GE248SU

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/08/2020

Event Type  malfunction  

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 ge248su - disp-saw blade rapid action 90/23/1.47mm.According to the complaint description, the blister pack was not sealed on one side.Packaged saw blade falls out.There was a unsterility in blister packaging.The case is reported precautionary, as a unsterile device can cause a infection.Additional information was not provided nor available / was not available.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Visual investigation: the packaging has been analysed visually.The failure mentioned by the customer can be confirmed.The outer packaging is open and not sealed.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 the risk assessment revealed that the overall risk level (severity 6 (10) probability of occurrence) according to din en iso 14971 is no longer acceptable.The need to revisit the risk assessment will be requested and further evaluated by the responsible department.Conclusion and measures / preventive measures: based on the current information and after the investigation, the failure is manufacturing related.The packaging was not sealed during the packaging process as intended.According to the statistical analysis, this is an individual case.There is no systematical problem.Furthermore, the sterility of the saw blade was not endangered because the primary packaging was still intact.The manufacturing department was informed about this case.Based upon the investigations resultsno capa is necessary.

• Brand Name: DISP.SAW BLADE RAPID ACTION 90/23/1.47MM
• Type of Device: LARGE BONE POWER SYSTEMS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10748872
• MDR Text Key: 213467395
• Report Number: 9610612-2020-00742
• Device Sequence Number: 1
• Product Code: GFA
• Combination Product (y/n): N
• PMA/PMN Number: A883359
• 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: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GE248SU
• Device Catalogue Number: GE248SU
• Device Lot Number: 52611940
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2020
• Date Manufacturer Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1