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

Catalog Number	299966724
Medical Device Problem Codes	Break (1069); Device-Device Incompatibility (2919); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # :(b)(4).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.
Event or Problem Description
It was reported that the emphasys offset cup adapter threads were stripped.It could not attach implant.Did not delay the case.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary it was reported that the emphasys offset cup adapter threads were stripped.It could not attach implant.Did not delay the case.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual inspection of the returned sample revealed the threads of mto emsys acet cup ins adaptor were heavily stripped.Based on the observed condition of the device the investigation was able to confirm the reported event.No other problem identified.A root cause for the observed damage was not established.The allegation of unable to assemble can be confirmed as it is reasonable to conclude that the allegation was due to the observed damage in the threads.No evidence of breakage was observed.The overall complaint was confirmed as the observed condition of the mto emsys acet cup ins adaptor would contribute to the complained device issue.Based on the investigation findings.The product issue has been addressed through depuy synthes quality system.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A records evaluation (mre) was not performed.

• 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): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17950854
• Report Number: 1818910-2023-21150
• Device Sequence Number: 20530718
• Product Code: HWA
• UDI-Device Identifier: 10603295526353
• UDI-Public: 10603295526353
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 10/17/2023

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2023
• Supplement Date Received by Manufacturer: 11/10/2023
• Initial Report FDA Received Date: 10/17/2023
• Supplement Report FDA Received Date: 11/11/2023
• 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
• Patient Sex: Male
• Patient Weight: 102 KG