MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MTO EMSYS ACET CUP INS ADAPTOR; HIP INSTRUMENT : INSERTER ADAPTOR

Catalog Number	299966724
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the emphasys inserter tip would not thread onto the cup so the inserter tip on the offset inserter was exchanged and it got stuck, rendering it unusable.The instruments were removed from the field and all pieces were retrieved.There was no surgical delay.
Additional Manufacturer Narrative
Product complaint # (b)(4).The manufacturing date is unidentified at this time.If additional information is received, a follow up regulatory report will be provided.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: MTO EMSYS ACET CUP INS ADAPTOR
• Common Device Name: HIP INSTRUMENT : INSERTER ADAPTOR
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): MACK TOOL & ENGINEERING; 2820 viridian drive; south bend IN 46628
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18218740
• Report Number: 1818910-2023-23862
• Device Sequence Number: 12189943
• Product Code: HWA
• UDI-Device Identifier: 10603295526353
• UDI-Public: 10603295526353
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 299966724
• Device Lot Number: MT107994
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2023
• Initial Report FDA Received Date: 11/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Male