MAUDE Adverse Event Report: DEPUY MITEK LLC US VERSALOK DEPLOYMENT GUN *EA; ORTHOPAEDIC IMPLANT INSERTER/EXTRACTOR

Model Number	214710
Medical Device Problem Codes	Material Twisted/Bent (2981); Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).The lot number was unknown.Investigation summary: according to the information provided, it was reported that during an unknown procedure the deployment gun got stuck to the inserter of the versalok and couldn´t be removed.The complaint device was received and evaluated.The visual inspection revealed that the device is discolored/fading off, scratches and nicks were discovered.The device showed that it was heavily used and is worn.The locking/ unlocking mechanism on the gun was tested several times and it was observed that the locking mechanism was not working while operating.It was slightly move and unlocking when operate the device.Also, it was not possible to driver shaft from the versalok, it was jammed.Therefore, this complaint can be confirmed.The distal part of the driver shaft was bent.As this is a reusable device, it is possible that tissue debris was lodged inside the shaft at the distal end and without proper cleaning/ sterilization; also adding a worn internal components; the device would become rough to operate over time, which may can cause jamming.For the damage can be attribute this type of failure when the device might have been dropped or device was tapped against a hard surface on several occasions.However, it cannot be conclusively affirmed.  as a potential cause cannot be associated to manufacturing, therefore a manufacturing record evaluation is not required.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes 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.
Event or Problem Description
It was reported by the sales rep that during an unknown procedure, it was observed that the deployment gun device got stuck to the inserter of the versalok; and could not be removed.During in-house engineering evaluation, it was determined that the driver shaft was jammed and its distal part was bent.Another device was used to complete the procedure.There were no adverse patient consequences or surgical delay reported.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Common Device Name: ORTHOPAEDIC IMPLANT INSERTER/EXTRACTOR
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10823392
• Report Number: 1221934-2020-03436
• Device Sequence Number: 3931800
• Product Code: LXH
• UDI-Device Identifier: 10886705004416
• UDI-Public: 10886705004416
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 11/02/2020

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: 214710
• Device Catalogue Number: 214710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2020
• Initial Report FDA Received Date: 11/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1