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

Catalog Number 211042

Device Problem Peeled/Delaminated (1454)

Patient Problems No Consequences Or Impact To Patient (2199); Injury (2348); No Code Available (3191)

Event Date 10/04/2019

Event Type  Injury  

Manufacturer Narrative

Udi: (b)(4).Reporter is company sales consultant.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 Description

It was reported by the sales rep that the lupine loop rapide anchor w/orthocord ds could not be used due to the failure of the lupine - spiral fluted drill bit which was causing metal shavings in the procedure and they were successfully removed.The case was completed with new drill bit and drill hole, new lupine.No patient consequences nor surgical delay.This is report 1 of 1 for complaint (b)(4).

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.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.Investigation summary : the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 1207001 number, and no non-conformances were identified.Since the complaint device was discarded, we cannot determine a root cause for the reported failure.If additional information is received in the future, we will reopen the complaint and perform the investigation as appropriate.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).

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.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.Udi: (b)(4).The lot number is unknown.

Event Description

Additional information received from the sales representative reported the lupine loop rapide anchor with orthocord pulled out of the bone.It was reported the case was completed by using a new drill bit, drilling a new bone hole, and utilizing a new lupine anchor.The sales representative reported all alternative products were readily available and additional surgical intervention is not planned.

• Brand Name: LUPINE SPIRAL FLUTED DRILL BIT
• Type of Device: SURGICAL HAND DRILL
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9256866
• MDR Text Key: 207200207
• Report Number: 1221934-2019-59341
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 10886705001545
• UDI-Public: 10886705001545
• 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,Followup,Followup
• Report Date: 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 211042
• Device Lot Number: 1207001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/03/2019
• Patient Sequence Number: 1