MAUDE Adverse Event Report: AESCULAP AG METHA ¿CAP 12/14 120°/0° SIZE 2; HIP ENDOPROSTHETICS

Model Number	NC292T
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported to aesculap ag that a metha ¿cap 12/14 120°/0° size 2 (part # nc292t) was used during a procedure performed on (b)(6) 2021.According to the complainant, during the procedure, when the metha implant no.2 was inserted into the bone, it sank deeper than the position where it could be fixed.The implant was removed, and then the procedure was successfully completed using another implant.The complaint device was returned to the manufacturer for evaluation.The patient had no infection and no health hazard was reported.Although requested, additional information has not been made available.The adverse event / malfunction is filed under (b)(4).
Additional Manufacturer Narrative
Investigation results: visual investigation: optically, signs of usage of erratic appearance can be found at the stem.Signs of usage and slight damages, especially on the plasmapore coating as well as at the neck area, can be found on the implant of erratic appearance.These signs originated most likely from the intraoperative inserting and removal respectively.Besides that, no abnormalities can be found.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 3(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: METHA ¿CAP 12/14 120°/0° SIZE 2
• 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: 12724483
• Report Number: 9610612-2021-00696
• Device Sequence Number: 3855389
• Product Code: LZO
• UDI-Device Identifier: 04046963914233
• UDI-Public: 4046963914233
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K112682
• 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
• Report Date (Section B): 03/04/2022

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: NC292T
• Device Catalogue Number: NC292T
• Device Lot Number: 52581533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2021
• Supplement Date Received by Manufacturer: 02/09/2022
• Initial Report FDA Received Date: 10/29/2021
• Supplement Report FDA Received Date: 03/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Sex: Female