MAUDE Adverse Event Report: DEPUY MITEK LLC US TENODESIS MODULAR DRIVER 23MM; SURGICAL SCREWDRIVER, REUSABLE

Catalog Number	219973
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Udi: (b)(4).Investigation summary: the complaint device was received and evaluated.Visual observation revealed that the distal end of the driver where the screw is loaded is slightly bent.Significant amount of nicks and marks were also observed on the distal part of the driver, indicating heavy usage.Moreover, the lot number on the device indicates that the device is approximately 6 years old.This failure has been consistent with application of excessive force over time.This complaint can be confirmed and the failure of the driver can be attributed to field wear due to repetitive excess force being applied.At this point in time, no corrective action is required and no further action is warranted.However, 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.This report is being filed as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event or Problem Description
It was reported by an employee via email that during an unknown procedure, at the start of the case, the 23 mm modular tenodesis driver tip of the shaft was bent.The case was completed by using a 30 mm driver to screw in the milgro anchor with no patient harm or delay.No additional information was provided.

• Brand Name: TENODESIS MODULAR DRIVER 23MM
• Common Device Name: SURGICAL SCREWDRIVER, REUSABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9125336
• Report Number: 1221934-2019-58608
• Device Sequence Number: 2820003
• Product Code: LXH
• UDI-Device Identifier: 10886705021796
• UDI-Public: 10886705021796
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/07/2019

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: 219973
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2019
• Initial Report FDA Received Date: 09/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1