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

Catalog Number	211042
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	04/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi#: (b)(4).The lot number was unknown.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained.
Event or Problem Description
This is report 3 of 4 for the same event.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.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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.Investigation summary: the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.Hence, this complaint cannot be confirmed.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.If any additional information is obtained, this complaint will be re-opened to capture that information.Furthermore, no lot numbers were provided which precludes conducting a manufacturing record review.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.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.
Event or Problem Description
This is report 3 of 4 for the same event.It was reported by the sales rep via phone that during inspection of the devices, it was identified that two of the customer's lupine spiral fluted drill bits and two of the customer's gryphon drill bits were dull.There was no patient involvement.The lot numbers are unknown.Two devices are being returned for evaluation and the other two were discarded.
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.H10 additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Correction: the device was returned and fully evaluated.The investigation summary(h10), method code (h6), device codes (h6), and result codes (h6) were corrected to reflect the evaluation of the device.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, likely from repeated use and sterilization cycles.This complaint can be confirmed.The likely root cause is fair wear and tare due to age and use.Furthermore, no lot numbers were provided which precludes conducting a manufacturing record review.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.

• 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: 8583103
• Report Number: 1221934-2019-57037
• Device Sequence Number: 18906220
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,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
• 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: 06/14/2019; 07/09/2019; 06/19/2019
• Initial Report FDA Received Date: 05/06/2019
• Supplement Report FDA Received Date: 06/14/2019; 07/10/2019; 07/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1