MAUDE Adverse Event Report: DEPUY MITEK LLC US GII/SUPER/RC DRGDE SLOT *EA; SURGICAL HAND DRILL

Model Number 213207

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 11/01/2020

Event Type  malfunction  

Manufacturer Narrative

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: according to the information provided, it was reported that two blind devices were received in decontamination site on 12/09/2020 with no complaint information attached and could not be associated with an existing complaint.The devices 213207 (bone tendon bone guide) and 213719 (rigidfix femrod 9.5mm *ea) were received and evaluated.When performing the visual inspection, it could be observed that both devices are attached one to the other and cannot be separated.The lock screw that keeps attached the rigidfix rod with the bone guide was found to be broken, a little portion of the screw remains inside the locking point, therefore the devices cannot be separated.The broken lock knob was not returned.No other anomalies were found.Since this is a reusable device, this failure possibly occurred after hard and rough use for many procedures leading to a lock screw breakage.However, this cannot be conclusive determined.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 Description

It was reported that during decontamination, it was observed that the device had an unspecified malfunction.During in-house engineering evaluation, it was determined that the lock screw that attaches the rigidfix rod with the bone guide was found to be broken that a little portion of the screw remained inside the locking point; and therefore the devices could not be separated.There was no procedure involved.No additional information was provided.

• Type of Device: SURGICAL HAND DRILL
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 11065254
• MDR Text Key: 223775627
• Report Number: 1221934-2020-04048
• Device Sequence Number: 1
• Product Code: FZX
• UDI-Device Identifier: 10886705002610
• UDI-Public: 10886705002610
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 12/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 213207
• Device Catalogue Number: 213207
• Device Lot Number: 1908001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2020
• Date Manufacturer Received: 12/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1