MAUDE Adverse Event Report: DEPUY MITEK LLC US GRYPHON T BR DS ANCH W/OC; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	210811
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Not Applicable (3189); No Code Available (3191)
Date of Event	07/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).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 or Problem Description
It was reported by the affiliate via email that during surgery three gryphon t br ds anchor tried to be implanted, which detached and could not be implanted.Additional information received from the affiliate reported 3 devices; product code 210811, of lot l630469 were used during the procedure.It was also reported there was an hour surgical delay with no patient consequences and the procedure was successfully completed with another anchor; product code 222245.The affiliate also reported the failure of the device occurred when the surgeon implanted the anchor and then pull the sutures the anchor detached.It was stated the devices are available for return.
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.H10 additional narrative: h3, h6: 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.One possible root cause for the reported problem could be the excessive force was applied while pulling the suture resulting in the anchor detachment.However without the return of the complaint device, and no further information provided we cannot determine a definitive root cause.No non-conformances were identified for this part number, lot number combination per qlik query executed on 8/1/2019.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.H3, h4, h6: a review of the device history record.Device history lot non-conformance's were identified for this part number, lot number combination per qlik query executed on 8/1/2019.Device history batch, device history review null.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: GRYPHON T BR DS ANCH W/OC
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8920105
• Report Number: 1221934-2019-58087
• Device Sequence Number: 16718101
• Product Code: MAI
• UDI-Device Identifier: 10886705001255
• UDI-Public: 10886705001255
• Combination Product (Y/N): N
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2019

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 Expiration Date: 11/30/2020
• Device Catalogue Number: 210811
• Device Lot Number: L630469
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/26/2019
• Supplement Date Received by Manufacturer: 09/19/2019
• Initial Report FDA Received Date: 08/22/2019
• Supplement Report FDA Received Date: 10/15/2019
• Patient Sequence Number: 1