MAUDE Adverse Event Report: AESCULAP AG BIPOLAR CUP HANDLE F/TRIAL HEADS STR; HIP ENDOPROSTHETICS

Model Number NF770R

Device Problem Material Fragmentation (1261)

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

Event Date 01/06/2022

Event Type  Injury  

Event Description

It was reported to aesculap ag that a bipolar cup handle f/trial heads str (part # nf770r) was used during a procedure performed on (b)(6) 2022.According to the complainant, the tip of the trial handle broke during surgery.During surgery, the tip of the nf770r deviated from the handle body.Since this event occurred when the nf770r was installed in the bipolar cup trial, the tip remained inside the cup.The remained bipolar cup was close to the planned size, so the doctor removed the tip part and tried to use it, but could not remove it.The procedure was able to be successfully completed using another size device.The complaint device has not been returned to the manufacturer for evaluation.An additional medical intervention was necessary.Although requested, additional information has not been made available.The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.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.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results a capa is not necessary.

Manufacturer Narrative

More cc's were added after the product was sent back to manufacturer for investigation.New investigation will be done and investigation results will be updated.New investigation results will be updated in the next follow up report.

Event Description

Correction: added associated medwatch and involved component.More cc's were added after the product was sent back to manufacturer for investigation.New investigation will be done and investigation results will be updated.New investigation results will be updated in the next follow up report.Associated medwatch-reports: 9610612-2022-00060 ((b)(6) - nf771r).9610612-2022-00004 ((b)(6) - nf770r).Involved components: ng094 - bipolar cup trial head id26mm od44mm - lot unknown.

Event Description

Associated medwatch-reports: 9610612-2022-00060 ((b)(6) - nf771r).9610612-2022-00004 ((b)(6) - nf770r).Involved components: ng094 - bipolar cup trial head id26mm od44mm - lot unknown.

Manufacturer Narrative

Updated h6: codes.Investigation results: visual investigation: the investigation was carried out visually and microscopically.The working end of nf770r has detached from the shaft.Here we found a loosened solder joint at the working end of nf770r.The other products show no visible damages.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.The review of risk assessment revealed that the overall risk level (severity 1(5) x probability of occurrence 2(5)) 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: BIPOLAR CUP HANDLE F/TRIAL HEADS STR
• Type of Device: HIP ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 13458320
• MDR Text Key: 286335749
• Report Number: 9610612-2022-00004
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 04038653114528
• UDI-Public: 4038653114528
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/26/2022

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: NF770R
• Device Catalogue Number: NF770R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/07/2022
• Initial Date FDA Received: 02/04/2022
• Supplement Dates Manufacturer Received: 02/15/2022; 05/10/2022
• Supplement Dates FDA Received: 03/11/2022; 05/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: NG094 - LOT UNKNOWN.; NG094 - LOT UNKNOWN.
• Patient Outcome(s): Required Intervention
• Patient Sex: Female