MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL HD EPSCP,1.9,30,60,MITEK; ARTHROSCOPE

Catalog Number	242095
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
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 complaint device was received at the manufacturing site and evaluated.During the service evaluation the following defects were identified: outer tube damaged, needle outer tube bent badly bent needle/bulged, outer tube damaged, distal tip distal tip damaged, laser welding damaged, needle welded seam cracked, optical system, optical components broken lenses in optical system distal cover glass/negative damaged scratched/residue, cosmetic issue scratches/dents.¿ broken (2+ pieces) : device fractured.¿ visual : deformed/bent.¿ visual : scratched/nicked.¿ labeling : illegible etch.Per service reports, this complaint cannot be confirmed.The defective parts needs to be replaced to resolve the issues.The faulty parts was identified as the root cause for the device failure during the service evaluation.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.At this point in time, no corrective action is required, and no further action is warranted.Depuy mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.Device history review: manufacturing record evaluation is not required as the reported event is not associated with the manufacturing process and/or the potential cause of the defect cannot be associated to manufacturing.H4: the date of manufacture was unknown.
Event or Problem Description
It was reported by the affiliate that during inspection, it was determined that the hd epscp,1.9,30,60,mitek device scopes shafts are bent.During in-house engineering evaluation, it was determined that the device fractured into two, was bent, the tube was damaged, the labelling etching was illegible and the housing was scratched/nicked.There was no procedure involved.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 correction: during further investigation it was determined that the reported condition was confirmed.
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 mitek or its employees that the report constitutes an admission that the device, 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.Device was used for treatment, not diagnosis.H11: additional narrative: updated device evaluation: upon further investigation, the evaluation of the device has been revised with the following findings: investigation summary the complaint device was received at the manufacturing site and evaluated.During the service evaluation the following defects were identified: outer tube damaged, needle outer tube bent badly bent needle/bulged, outer tube damaged, distal tip distal tip damaged, laser welding damaged, needle welded seam cracked, optical system, optical components broken lenses in optical system distal cover glass/negative damaged scratched/residue, cosmetic issue scratches/dents, engraving/identification datamatrix code level f.Broken (2+ pieces) : device fractured, visual : deformed/bent, visual : scratched/nicked, labeling : illegible etch per service reports, this complaint was confirmed.Based on the investigation findings, the faulty parts were identified as the root cause for the device failure during the service evaluation.It has been determined that no corrective and/or preventative action is proposed and there is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics 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.

• Brand Name: HD EPSCP,1.9,30,60,MITEK
• Common Device Name: ARTHROSCOPE
• 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: 19939846
• Report Number: 1221934-2024-02763
• Device Sequence Number: 14684698
• Product Code: HRX
• UDI-Device Identifier: 10886705031917
• UDI-Public: (01)10886705031917
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K080560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/08/2024

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: 242095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2024
• Supplement Date Received by Manufacturer: 11/14/2024; 11/25/2024
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 11/15/2024; 11/26/2024
• 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: Unknown