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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US DRILL GUIDE GII/SUPER/RC/GLS; SURGICAL HAND DRILL
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DEPUY MITEK LLC US DRILL GUIDE GII/SUPER/RC/GLS; SURGICAL HAND DRILL Back to Search Results
Catalog Number 213107
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/07/2017
Event Type  malfunction  
Manufacturer Narrative
Product complaint #
=
> (b)(4).Device was used for treatment, not diagnosis.Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi is currently unavailable.Depuy synthes has been informed that the catalog number and lot number are not available.
 
Event Description
It was reported that the super rc kit was used during the olecranon ligament repair.When the surgeon inserted the drill through the drill guide, a black-colored foreign matter like some sort of residue (chunk) came out from the drill guide.The surgeon stopped using the complaint device and switched to another competitive device to complete the procedure.There was a delay in surgery and no harm to the patient.
 
Manufacturer Narrative
Product complaint # (b)(4).Device was used for treatment, not diagnosis.The drill guide was received and examined under magnification for any scratches or burrs along the length of the shaft and at the tip to cause this failure.There were no anomalies found on the drill guide.Some photos of the black substance were provided.A pouch containing some black debris was also returned along with the complaint device.However, there was no way to confirm that the debris came out of the drill guide.Moreover, no debris was observed on the actual device.We cannot confirm this complaint or determine a root cause for this failure mode at this point.Two drill bits were returned along with the complaint device.However, there was no complaint noted on those.Also, no apparent anomalies could be observed visually.These devices were noted in the section for concomitant devices.No further action is warranted.Furthermore, no lot numbers were supplied for the complaint device which precludes conducting a device history record review or a lot specific search in the complaints handling system.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.Udi: unavailable.Depuy synthes has been informed that the lot number is not available.
 
Event Description
It was reported that the super rc kit was used during the olecranon ligament repair.When the surgeon inserted the drill through the drill guide, a black-colored foreign matter like some sort of residue (chunk) came out from the drill guide.The surgeon stopped using the complaint device and switched to another competitive device to complete the procedure.There was a delay in surgery and no harm to the patient.Additional information obtained from the affiliate via e-mail on 01-17-2018: there was a 10-min delay in surgery.The foreign matter was observed when the surgeon was inserting the drill through the drill guide.The product code for the returned product was 213107.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Mfr site: physical manufacturer.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.
 
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Brand Name
DRILL GUIDE GII/SUPER/RC/GLS
Type of Device
SURGICAL HAND DRILL
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
MDR Report Key7187550
MDR Text Key97862278
Report Number1221934-2018-50052
Device Sequence Number1
Product Code HTW
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 12/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number213107
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/15/2018
Date Manufacturer Received06/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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