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

Catalog Number 210813

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Injury (2348)

Event Date 01/18/2019

Event Type  Injury  

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.(b)(4).

Event Description

It was reported by the affiliate via email that during an arthroscopic bankart repair the surgeon implanted the first anchor and it backed out right after being implanted into the shoulder.Then, with the different bone hole created, the surgeon implanted the second anchor, which broke.Finally, the surgery was completed by using alternative anchor with another bone hole.There were no broken parts in the patient¿s body.It was brand new and the first use when the issue occurred.There was no harm to the patient.

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.The complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.Hence, this complaint cannot be confirmed.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.Furthermore, a non-conformance search was conducted and no non-conformances were identified for this part number (210813), lot number (1l29572) combination.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).

• 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: 8307878
• MDR Text Key: 135143226
• Report Number: 1221934-2019-56334
• 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: foreign
• Type of Report: Initial,Followup
• Report Date: 01/21/2019

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 Expiration Date: 09/30/2021
• Device Catalogue Number: 210813
• Device Lot Number: 1L29572
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/21/2019
• Initial Date FDA Received: 02/05/2019
• Supplement Dates Manufacturer Received: 02/15/2019
• Supplement Dates FDA Received: 02/21/2019
• Patient Sequence Number: 1