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

Catalog Number 210813

Device Problems Migration or Expulsion of Device (1395); Deformation Due to Compressive Stress (2889); Material Twisted/Bent (2981)

Patient Problems Tissue Damage (2104); No Consequences Or Impact To Patient (2199)

Event Date 10/31/2018

Event Type  Injury  

Manufacturer Narrative

If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4).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 that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This is report 1 of 2 for the same event.It was reported by the affiliate in the (b)(6) that during bankart repair, it was observed the screw tip of the two gryphon p br ds anchor w/oc implant devices were deformed.It was not reported, if there was a delay in the surgery or, if a spare device was available for use.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.

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.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 non-conformance search was performed for this part(210813), lot(3906210) combination and no non-conformances were identified.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.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

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 additional information should become available, a supplemental medwatch will be submitted accordingly.Additional information: subsequent follow-up with the customer, additional information was received.The reporter confirmed that the device has been discarded and will not available for return.

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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Additional information received from the affiliate on 01/11/2019 stating that the adverse event was a possible pullout of implant from the bone on (b)(6) 2018.The case was completed by opening another stock.Additional information was received by the affiliate on 01/16/2019 stating that the event occurred inta-op.There was a surgical delay of 5 minutes.There was no patient harm due to this delay.The case was completed with another readily available device.The affiliate also stated that the surgeon was not off-axis while they were using the implant and there was no debris left in the patient.The same bone hole was used to complete the procedure.The complaint was not entered until 12/17/2018 because the affiliate was unaware of the complaints process.

• Brand Name: GRYPHON P BR DS ANCHOR W/OC
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8196026
• MDR Text Key: 131520837
• Report Number: 1221934-2018-55816
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705001279
• UDI-Public: 10886705001279
• 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,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/31/2018

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 Expiration Date: 04/30/2019
• Device Catalogue Number: 210813
• Device Lot Number: 3906210
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/31/2018
• Initial Date FDA Received: 12/26/2018
• Supplement Dates Manufacturer Received: 01/02/2019; 01/11/2019; 01/28/2019
• Supplement Dates FDA Received: 01/07/2019; 01/17/2019; 01/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1