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

Catalog Number 210808

Device Problems Corroded (1131); Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/12/2023

Event Type  malfunction  

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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: e3: reporter is a j&j sales representative.Udi: (b)(4) as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.

Event Description

It was reported by the sales rep in china that during an unspecified surgical procedure on (b)(6) 2023 the versalok pre packed w/oc device anchor pulled out.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.

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.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.H10 additional narrative: d9, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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.Upon visual inspection of the photo, it could be observe that the titanium pin is till attached to the inserter, it does not have structural anomalies.Foreign matter, presumably biological matter could be observed in the device.The sleeve was not shown in the photo.A manufacturing record evaluation was performed for the finished device 191l269 number, and no non-conformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.According with the visual inspection result, this complaint can be confirmed.A possible root cause can be attributed to procedural variables, such handling of the device or product interaction during procedure.However, it cannot be conclusively determined.As per ifu: bone stock must be adequate to allow proper and secure anchor placement.Incomplete insertion or over tensioning or poor bone quality may result in anchor pullout.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.

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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: the complaint device was received and evaluated.On visual inspection, the anchor remains attached on the shaft.The anchor peek dilator is slightly scratched due to the bone surface rubbing.Biological matter can be observed on the peek dilator and anchor.A manufacturing record evaluation was performed for the finished device 191l269 number, and no non-conformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.According with the visual inspection result, this complaint can be confirmed.The possible root cause can be attributed to procedural variables, such handling of the device or product interaction during procedure; an incomplete insertion or poor bone quality may happen, as per ifu 108978; bone stock must be adequate to allow proper and secure anchor placement.Incomplete insertion or over-tensioning or poor bone quality may result in anchor pullout.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.Device history review pn:210808.Lot number:191l269.There was no non conformance regarding this lot.Manufacturing date: 19 jun 2023.Expiry date: 31 may 2026.Quantity: (b)(4).Release date: 07 jul 2023.

• Brand Name: VERSALOK PRE PACKED W/OC
• Type of Device: 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 02767 ; 3035526892
• MDR Report Key: 17974719
• MDR Text Key: 326129556
• Report Number: 1221934-2023-03810
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 10886705001224
• UDI-Public: 10886705001224
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K063478
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 210808
• Device Lot Number: 191L269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1