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

Catalog Number	223146
Medical Device Problem Codes	Entrapment of Device (1212); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.(b)(4).Investigation summary: the complaint device was not returned by the customer therefore, device is not available for a physical evaluation.No pictures were provided.This complaint is not confirmed.As reported the suture broke when the anchor after the anchor was inserted in the bone hole.A new bone had to be used.No further information regarding the procedure or the device used has been provided to determine a root cause for this failure.A non-conformance search was performed for this part#: 223146, lot#:l604137 combination and no nonconformances were identified.At this point in time, no corrective action is required, and no further action is warranted.This file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue.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
This is report 1 of 4 for the same event.It was reported by the sales rep via phone that during a shoulder repair procedure two of the sales rep's gryphon br anchors with permacord (lot: l604137) were inserted into the patient, but after the surgeon tied the knot in the suture, the suture came loose.The same failure occurred for two of the sales rep's gryphon ds anchors with permacord (lot: l918851).The sales rep stated that the case was completed by drilling over the anchors to implant competitor anchors.The sales rep stated another bone hole was created and a competitor's anchor was implanted.There was no time delay to the case.The anchors are not being returned, as they are implanted in the patient.There was patient involvement reported.It was not reported if there was prolonged hospitalization.The status of the patient post-surgery was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: GRYPHON P BR W PERMACORD
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8143617
• Report Number: 1221934-2018-55596
• Device Sequence Number: 1910178
• Product Code: MAI
• UDI-Device Identifier: 10886705024629
• UDI-Public: 10886705024629
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K133794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/05/2018

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: 09/30/2020
• Device Catalogue Number: 223146
• Device Lot Number: L604137
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2018
• Initial Report FDA Received Date: 12/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention