MAUDE Adverse Event Report: DEPUY MITEK LLC US MINI DRBIT 2.1MM *EA; SURGICAL HAND DRILL

Catalog Number	211083
Medical Device Problem Codes	Dull, Blunt (2407); Failure to Cut (2587)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).The lot number is unknown.
Event or Problem Description
It was reported that the surgeon recognized that the drill tip (p/n and lot# were unknown) was dull, so that the surgeon could not create pilot hole for mini quick anchor plus (p/n and lot# were unknown) during the surgery on (b)(6) 2019.The surgery was finished without any other problem although it was not reported how the surgery was completed.It was brand new and the first use when the issue occurred.There was no information of surgical delay and no harm to the patient.No further information was provided by the hospital.Additional information provided by affiliate reporting a mini quick anchor was used during the procedure but the lot number is unknown.
Additional Manufacturer Narrative
Product complaint # (b)(4).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 h11: g4 date (6/27/2019) provided on follow-up 2 was incorrect, the correct date is: 9/13/2019.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary the device was received and evaluated.Upon visual evaluation under magnification, it can be noticed that the distal section of the tip of the drill bit appears to be dull.The complaint is confirmed.Given the information provided, it is not clear how the tip became dull.A possible root cause can be attributed to wear and tear due to repeated sterilization cycles.A lot number was not provided; therefore, a manufacturing record evaluation search for non-conformances could not be conducted.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.Device history lot a lot number was not provided; therefore, an manufacturing record evaluation search for non-conformances could not be conducted.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.
Additional 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.H3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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.

• Common Device Name: SURGICAL HAND DRILL
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8824376
• Report Number: 1221934-2019-57781
• Device Sequence Number: 343343
• Product Code: HTW
• UDI-Device Identifier: 10886705001569
• UDI-Public: 10886705001569
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/27/2019

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: 211083
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2019
• Initial Date Received by Manufacturer: 06/27/2019
• Supplement Date Received by Manufacturer: 07/26/2019; 06/27/2019; 09/17/2019
• Initial Report FDA Received Date: 07/24/2019
• Supplement Report FDA Received Date: 08/26/2019; 09/16/2019; 09/17/2019
• Patient Sequence Number: 1