MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL SHE_2RSTCK_5.9,UNIV,167_MITEK; ACCESSORIES, ARTHROSCOPIC

Catalog Number	242032
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported from the sales rep that during cleaning/sterilization process it was observed that the she_2rstck_5.9,univ,167_mitek device "stop cock, mitek lock has the screw on the stopcock leaver on the sheath broke off and as a result the stopcock leaver handle came apart".This event did not occur during surgery.There was no delay in the procedure reported.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by depuy mitek or its employees that the report constitutes an admission that the device, depuy mitek, 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 medwatch, a follow-up medwatch will be filed as appropriate.H11 additional narrative: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.H4: the device manufacture date was unknown.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by depuy mitek or its employees that the report constitutes an admission that the device, depuy mitek, 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 medwatch, a follow-up medwatch will be filed as appropriate.H4: the date of manufacture has been added.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by depuy mitek or its employees that the report constitutes an admission that the device, depuy mitek, 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 medwatch, a follow-up medwatch will be filed as appropriate.D9, h3, h6: the actual device has been returned and is currently pending evaluation.Once the investigation has been completed, a supplemental medwatch report will be submitted accordingly.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by depuy mitek or its employees that the report constitutes an admission that the device, depuy mitek, 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 medwatch, a follow-up medwatch will be filed as appropriate.H11 additional narrative: the product was returned to j&j medtech orthopaedics for evaluation.J&j medtech orthopaedics then conducted visual inspection of the device received.The complaint device was received and evaluated.Upon visual inspection, it was observed that one of the knobs of the she_2rstck_5.9,univ,167_mitek was not returned for evaluation, therefore one of the stopcocks was detached from the tunnel.The rest of the device does not show anomalies.The overall complaint was confirmed as the observed condition of the she_2rstck_5.9,univ,167_mitek would have contributed to the complained device issue.Based on the investigation findings and since the knob was not returned for physical evaluation, it is not possible to identify the breakage reported, however the potential root cause for the missing knob can be attributed to procedural variables during or post cleaning/sterilization processes; the device knob may have not been reassembled and consequently lead to missing components.As per ifu make sure all of the o-rings are in place on the body.Reassemble the stopcock(s) to the bridge.Assemble the bridge to the body.Install the knurled nut to hold the bridge in place on the sheath.Therefore it has been determined, no corrective action is required, and no further action is warranted.However, j&j medtech orthopaedics will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.A manufacturing record evaluation was performed for the finished device, and no non-conformances were identified.

• Brand Name: SHE_2RSTCK_5.9,UNIV,167_MITEK
• Common Device Name: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 20239998
• Report Number: 1221934-2024-03264
• Device Sequence Number: 8163587
• Product Code: NBH
• UDI-Device Identifier: 10886705031641
• UDI-Public: (01)10886705031641(10)1699848
• Combination Product (Y/N): N
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/17/2024

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: 242032
• Device Lot Number: 1699848
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2024
• Supplement Date Received by Manufacturer: 09/16/2024; 10/02/2024; 10/09/2024
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 09/20/2024; 10/03/2024; 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/03/2022
• 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: Unknown