MAUDE Adverse Event Report: DEPUY MITEK LLC US LUPINE SPIRAL FLUTED DRILL BIT; SURGICAL HAND DRILL

Catalog Number	211042
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).The lot number is currently unknown.
Event or Problem Description
It was reported by the sales rep via phone that during a shoulder repair procedure two of the customer's lupine spiral fluted drill bits and two of the customer's gryphon drill bits were dull.The case was completed with one of the four devices, but the sales rep did not know which one.There was no patient harm or delay.The sales rep was not present and could not provide the lot numbers of the devices or any additional information.The devices are being returned for evaluation.Additional information provided by the sales rep reported that there were 6-drill bits(sharp) instead of the 4-drill bits initially reported.
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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the device was received and evaluated.Visual inspection under magnification reveals that the device has several nicks and chips on the distal end of the device.Also, the sharp edges are flattened.The device is dull and worn from repeated uses and sterilization cycles.The lot number was not reported for this device.The lot number marking on the device has faded and cannot be identified.The faded laser marking indicates that the device is old.This complaint can be confirmed.This failure can be attributed to fair wear and tear of the device due to repeated use and sterilization cycles.No review could be conducted per qlik query because the lot number is unknown.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: (b)(4).The lot number is unknown.
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.The initial complaint was reviewed and found not reportable.This part will be voided as it was incorrectly added to this complaint, therefore the mw will be retracted.This part and mw are captured under complaint (b)(4).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.

• Brand Name: LUPINE SPIRAL FLUTED DRILL BIT
• Common Device Name: SURGICAL HAND DRILL
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8651149
• Report Number: 1221934-2019-57211
• Device Sequence Number: 11284465
• Product Code: HTW
• UDI-Device Identifier: 10886705001545
• UDI-Public: 10886705001545
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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,Followup,Followup
• Report Date (Section B): 04/15/2019

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: 211042
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2019
• Initial Date Received by Manufacturer: 04/15/2019
• Supplement Date Received by Manufacturer: 06/02/2019; 07/10/2019
• Initial Report FDA Received Date: 05/29/2019
• Supplement Report FDA Received Date: 06/04/2019; 07/10/2019
• Patient Sequence Number: 1