MAUDE Adverse Event Report: DEPUY MITEK LLC US MINI QA+ 2/O OCORD V-5; STAPLE, FIXATION, BONE

Catalog Number	212035
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during service and evaluation, it was determined that the small battery drive device future was damaged - cut/broken and was missing components.It was reported in the service order that during a surgical procedure, when opening the container, it was found that it did not include the punch or the 2.0 bit, tried to replace the instrument using a needle, but did not get the expected result, so finally decided not to use the anchor or open the bit.There were no reports of delays to a surgical procedure.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.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.H11 additional narrative: photo investigation: the product and a photo have been returned to depuy synthes for evaluation.¿ visual inspection of the returned photo found the device in used condition sitting on the desiccating tray, the drill bit was not observed.The suture was cut.No other anomalies were noted.Device investigation: the product was returned to depuy synthes for evaluation.¿ visual inspection of the returned device found the device in used condition sitting on the desiccating tray, the drill bit was not returned.The suture was cut.No other anomalies were noted.The manufacturer performed an investigation of the device with the following results: based on the provided image, one missing component was identified.However, the device shown appears to have been clearly manipulated, as several components are displaced and not in their designated position within the tray.Due to the condition of the device and the lack of a controlled visual reference, it is not possible to perform a complete or conclusive analysis with the information available.A root cause cannot be clearly defined based on the available information.It is important to note that based on the description of the complaint, the device was manipulated after the presumed defect was found, the recommendation is to leave the device as-is for a proper evaluation.The overall complaint was confirmed as the observed condition of the mini qa+ #2/o ocord v-5 would have contributed to the complained device issue.¿ based on the investigation findings, a potential cause for the reported condition could not be established.The potential cause for the suture condition could be traced to the procedural variables, such handling of the device or product interaction during procedure.It has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.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.

• Brand Name: MINI QA+ 2/O OCORD V-5
• Common Device Name: STAPLE, FIXATION, BONE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INT MITEK; chemin blanc 38; le locle CH-02 400; SZ CH-02400
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 23794588
• Report Number: 1221934-2025-04733
• Device Sequence Number: 10476921
• Product Code: JDR
• UDI-Device Identifier: 10886705001835
• UDI-Public: (01)10886705001835(10)107918(17)280229
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K071257
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/12/2025

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: 212035
• Device Lot Number: 107918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/24/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown