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

Model Number	NF770R
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2022
Type of Reportable Event	Serious Injury
Event or Problem 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).
Additional 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.
Additional 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 or Problem 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 9610612-2022-00004
• Device Sequence Number: 4853917
• Product Code: HWT
• UDI-Device Identifier: 04038653114528
• UDI-Public: 4038653114528
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2022
• Supplement Date Received by Manufacturer: 02/15/2022; 05/10/2022
• Initial Report FDA Received Date: 02/04/2022
• Supplement Report FDA Received Date: 03/11/2022; 05/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NG094 - LOT UNKNOWN.; NG094 - LOT UNKNOWN.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female