MAUDE Adverse Event Report: AESCULAP AG CUP INSERT.INSTR.W/THREAD M8X1 STR SHORT; SPECIAL INSTRUMENTS FOR ACETAB

Model Number	NT414R
Medical Device Problem Code	Failure to Disconnect (2541)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
Event or Problem Description
It was reported that there was an issue with nt414r - cup insert.Instr.W/thread m8x1 str.According to the complaint description, the instrument could not be turned off after implantation of the plasmafit cup.Both impactors were used in the same surgery.The surgery was continued with a third-party product.An additional medical intervention was necessary.Additional information was not provided nor available / was not available.The adverse event / malfunction is filed under aag reference (b)(4).Involved component: nv254t - plasmafit plus 3 cup size 54mm h - batch: 52621612.
Additional Manufacturer Narrative
Investigation results: visual investigation: in the delivered condition the cups were already screwed off the thread of the nt414r.The first thread of both inserters (nt414r) show little damages.The thread of both cups (nv254t) show no damages or abnormalities.A function test was carried out on both nt414r using the cups supplied: in normal use, i.E.When the cup is screwed onto the thread of the inserter with normal force, it is easy to remove the impactor from the thread of the cup.In the course of the functional test it was found that the little damages on the first thread of both instruments have no influence on the further functionality.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 there are 2 similar complaints against the same lot number(s).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: CUP INSERT.INSTR.W/THREAD M8X1 STR SHORT
• Common Device Name: SPECIAL INSTRUMENTS FOR ACETAB
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10817182
• Report Number: 9610612-2020-00833
• Device Sequence Number: 2113849
• Product Code: LXH
• UDI-Device Identifier: 04046964027475
• UDI-Public: 4046964027475
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: A883011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2020

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: NT414R
• Device Catalogue Number: NT414R
• Device Lot Number: 52456802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2020
• Supplement Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 11/10/2020
• Supplement Report FDA Received Date: 12/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NV254T - BATCH: 52621612; NV254T - BATCH: 52621612; NV254T - BATCH: 52621612
• Outcome Attributed to Adverse Event: Required Intervention