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

Catalog Number	210812
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Tissue Damage (2104); No Consequences Or Impact To Patient (2199)
Date of Event	04/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).The expiration date is not currently available.
Event or Problem Description
Anchor broken during surgery.
Additional 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.
Event or Problem Description
Anchor broken during surgery.Additional information received on 5/16/2018 and 5/24/2018.The anchor break occurred during surgery when the surgeon try to put the anchor in the bone.This resulted in 30 minutes delay.All the implant debris were removed from patient and there was no patient consequences.The procedure completed with other anchor which was readily available.Surgical intervention was planned.Patient¿s bone quality was good.It was a off axis insertion and a new bone hole was used to complete the procedure.Were there any procedural or patient anatomy factors which may have contributed to the breakage? no.
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch or first follow-up, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).
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
Additional information received on 5/29/2018 stated that the device was returned for evaluation.It was reported that the delay was 30-min long resulting in adverse event.
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.Evaluation statement: the complaint device is not available for physical evaluation, hence, the complaint cannot be confirmed.At this time we cannot discern a root cause for the reported failure.A device history record (dhr) review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed.At this point, 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 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: 7474327
• Report Number: 1221934-2018-50544
• Device Sequence Number: 13809554
• Product Code: MAI
• UDI-Device Identifier: 10886705001262
• UDI-Public: 10886705001262
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 05/16/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 210812
• Device Lot Number: L374616
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/11/2018
• Supplement Date Received by Manufacturer: 05/16/2018; 05/29/2018; 11/05/2018; 10/15/2019
• Initial Report FDA Received Date: 04/30/2018
• Supplement Report FDA Received Date: 05/31/2018; 10/30/2018; 11/06/2018; 10/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other