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

Catalog Number	210031
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Injury (2348); Foreign Body In Patient (2687); Not Applicable (3189)
Date of Event	10/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.(b)(4).The complaint device is not being returned as it was discarded by the customer; therefore, this complaint cannot be confirmed and duplicated.The assignable root cause was not determined.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
It was reported by the sales rep via phone that during a hip surgery procedure, it was observed that the sales rep's gryphon peek anchor with orthocord broke in half during insertion.The sales rep stated that the proximal end of the anchor was removed with a grasper, but the distal end was removed using a drill bit.The sales rep stated that there could be debris left in the patient.The sales rep stated that the patient had hard bone and the surgeon was not off axis.The case was completed using two like-anchors in new bone holes on either side of the first bone hole.There was a three minute delay to remove the anchor.The anchor was discarded by the customer.The status of the patient post-surgery was not provided.It was not reported if there was a 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.
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.Investigation summary: the complaint device was discarded and not available for evaluation.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.A non-conformance search was performed for this part (210031), lot (l529172) combination and no non-conformance's were identified.Therefore, we cannot determine what caused the user to experience the reported event, we cannot discern a root cause for the reported failure mode.At this point in time, no corrective action is required, and no further action is warranted.However, should any new information be provided in future, this file will be re-opened, and a thorough investigation will be performed.Depuy 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 PEEK ANCHOR W/OC
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8025299
• Report Number: 1221934-2018-55151
• Device Sequence Number: 19115523
• Product Code: MAI
• UDI-Device Identifier: 10886705019946
• UDI-Public: 10886705019946
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K150209
• 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,Followup
• Report Date (Section B): 10/02/2018

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: 08/31/2020
• Device Catalogue Number: 210031
• Device Lot Number: L529172
• Initial Date Received by Manufacturer: 10/02/2018
• Supplement Date Received by Manufacturer: 11/10/2018
• Initial Report FDA Received Date: 10/31/2018
• Supplement Report FDA Received Date: 11/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1