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

Catalog Number 210712

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Not Applicable (3189); No Code Available (3191)

Event Date 09/30/2019

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.(b)(4).

Event Description

It was reported by the affiliate via cst that during a labral repair procedure, upon attempting to place the first anchor, the anchor pulled out of the bone when tension was applied to seat the anchor.Bone quality was good- the anchor just failed.A second anchor was opened and the surgeon attempted to place it very close to the original drill hole so as not to utilize more bone stock- this anchor pulled out as well.He may or may not have wound up placing it in the same drill hole, but nonetheless the anchor failed.Finally 3 more lupines were opened and successfully implanted and the case went on without further delay.A 15 minutes delay has been reported.The procedure has been completed by using new anchors.

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.No nonconformances were identified for this part number 210712, lot #3l18785 combination per qlik query executed on 11/27/2019.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).The expiration date is unknown.

Event Description

Additional information received from the affiliate reported the surgeon applied typical force when the anchor pulled out of the bone.It was reported all debris was completely removed from the patient and did not remain on the inserter after removal from the cannula.The affiliate reported the suture did not wrap around the handle and the surgeon did not grasp the suture on insertion.It was reported the surgeon used appropriate downward force while driving the anchor in and suture limbs were used to verify the repair.

• 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: 9244585
• MDR Text Key: 178626106
• Report Number: 1221934-2019-59246
• 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: 10/01/2019

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: Health Professional
• Device Catalogue Number: 210712
• Device Lot Number: 3L18785
• Initial Date Manufacturer Received: 10/01/2019
• Initial Date FDA Received: 10/28/2019
• Supplement Dates Manufacturer Received: 11/11/2019
• Supplement Dates FDA Received: 11/27/2019
• Patient Sequence Number: 1