MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH CAP INSERTER; DRIVER, PROSTHESIS

Model Number	277040700
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on (b)(6) 2021, the cap inserter was broken during reverse logistics audit of returned device at a third party servicer.There was no patient involvement and no additional information is available.This report is for one (1) cap inserter.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H6: visual inspection: cap inserter (p/n: 277040700, lot #:t0304) was returned and received at us customer quality (cq).Upon visual inspection, one of the distal teeth was observed to be broken on the returned device.Additionally, normal wear from field usage was also observed on the device.Device failure/defect identified? yes.Dimensional inspection: complaint relevant dimensions cannot be taken due to the post-manufacturing damage observed on the device.Document/specification review since the date of manufacturing is unknown the following drawing, reflecting current revision was reviewed: monarch cap inserter (long), assembly.Complaint confirmed? yes.Investigation conclusion the complaint was confirmed for the returned devices.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CAP INSERTER
• Common Device Name: DRIVER, PROSTHESIS
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 6103142063
• MDR Report Key: 12814911
• Report Number: 1526439-2021-02400
• Device Sequence Number: 19990971
• Product Code: HWR
• UDI-Device Identifier: 10705034196879
• UDI-Public: 10705034196879
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Other
• Initial Reporter Occupation: 505
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2021

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 Model Number: 277040700
• Device Catalogue Number: 277040700
• Device Lot Number: T0304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/22/2021
• Supplement Date Received by Manufacturer: 11/24/2021
• Initial Report FDA Received Date: 11/15/2021
• Supplement Report FDA Received Date: 12/20/2021
• 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