MAUDE Adverse Event Report: DEPUY MITEK LLC US LUPINE BR DS W/ORTHCRD; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number 210712

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Injury (2348); Not Applicable (3189)

Event Date 02/20/2020

Event Type  Injury  

Manufacturer Narrative

Product 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.Udi: (b)(4).

Event Description

It was reported by the sales rep via complaint submission tool that during a labral repair when using lupine br ds w/orthcord, after drilling and inserting the anchor and beginning to tie de knots, the surgeon noticed that the anchor had pulled out of the bone and he had to remove it.Another lupine br ds w/orthcord was opened and the surgeon attempted to place it very closely to the original bone hole even though he redrill.Again the same issue occurred with the anchor pulling out of the bone.The patients bone was suspect but he was upset.The case was successfully completed using another unit.No patient consequence, however there was a 10 minutes surgical delay reported.No additional information was provided.

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.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.H10 additional narrative: investigation summary: the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.A manufacturing record evaluation was performed for the finished device lot number (5l62747), and no non-conformances were identified.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 history lot: a manufacturing record evaluation was performed for the finished device lot number (5l62747), and no non-conformances were identified.

• Brand Name: LUPINE BR DS W/ORTHCRD
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9801824
• MDR Text Key: 188389342
• Report Number: 1221934-2020-00776
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705001101
• UDI-Public: 10886705001101
• Combination Product (y/n): N
• PMA/PMN Number: K150209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/31/2022
• Device Model Number: 210712
• Device Catalogue Number: 210712
• Device Lot Number: 5L62747
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/21/2020
• Initial Date FDA Received: 03/06/2020
• Supplement Dates Manufacturer Received: 03/23/2020
• Supplement Dates FDA Received: 03/24/2020
• Patient Sequence Number: 1