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

Model Number	210812
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).The expiration date is currently unavailable.According to the information provided, it was reported that utilizing a gryphon t br anchor w/orthocord, when the anchor broke on him upon insertion.As reported to rep, the tunnel had been drilled and the anchor was being inserted, but the anchor cracked as it began to make its way into the bone tunnel.All fragments were recovered, and no patient harm reported.The complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.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.A manufacturing record evaluation was performed for the finished device lot number: 6l78054, and no nonconformances 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.
Event or Problem Description
It was reported by sales rep that during an unknown procedure of the left arm on an unknown date, it was observed that the gryphon t br anchor w/orthocord device broke upon insertion into the bone tunnel.All fragments were recovered.Another like device was used to complete the procedure without delay.There were no adverse patient consequences reported.No additional information was provided.

• Brand Name: GRYPHON T BR ANCHOR 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: 11444895
• Report Number: 1221934-2021-00754
• Device Sequence Number: 4048601
• Product Code: MAI
• UDI-Device Identifier: 10886705001262
• UDI-Public: 10886705001262
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/24/2021

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 Model Number: 210812
• Device Catalogue Number: 210812
• Device Lot Number: 6L78054
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 03/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1