MAUDE Adverse Event Report: DEPUY MITEK LLC US VERSALOK PRE PACKED W/OC; SCREW, FIXATION, BONE

Catalog Number	210808
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2024
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 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.H11 additional narrative: h4: the device manufacture date is currently unavailable.The investigation has been updated to reflect the correct information: investigation summary : a photo was returned to depuy synthes mitek for evaluation.The depuy synthes mitek team conducted a visual inspection of the returned photo.Visual analysis of the photo reveled that the anchor appears to be detached from the inserter.The overall complaint was confirmed as the observed condition of the versalok pre packed w/oc would contribute to the complained device issue.Based on the investigation findings, the possible root cause can be traced to procedural variables, such handling of the device or product interaction during procedure; the anchor could have incompletely inserted and consequently the anchor was not secured.As per ifu incomplete insertion or over tensioning or poor bone quality may result in anchor pullout.While keeping nominal tension on the suture strands, place the shaft against bone at the selected fixation site and confirm that the suture is not twisted.If the suture is twisted, untwist the suture.Tap the back end of the shaft with a mallet, driving the anchor into bone.Continue tapping until contact with the distal edge of the laser line, which is directly before the shoulder of the pusher is in contact with the bone surface.In hard bone, the awl may be used first to create a starter hole.Optional: place the end cap on the shaft to increase the surface area for the mallet to strike.Has been determined that no corrective and/or preventative action is required.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.
Event or Problem Description
It was reported by the healthcare professional in china that during a rotator cuff repair surgical procedure on (b)(6) 2024 the versalok pre packed w/oc device could not secure the anchor.Another like device was used to complete the procedure.There was no delay in the procedure reported.There were no adverse patient consequences reported.No additional information was provided.

• Brand Name: VERSALOK PRE PACKED W/OC
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raymham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA ; 3035526892
• MDR Report Key: 19372320
• Report Number: 1221934-2024-01682
• Device Sequence Number: 18073565
• Product Code: HWC
• UDI-Device Identifier: 10886705001224
• UDI-Public: 10886705001224
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K063478
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/22/2024

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 Expiration Date: 05/31/2026
• Device Catalogue Number: 210808
• Device Lot Number: 143L555
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2024
• Initial Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown