MAUDE Adverse Event Report: CAYENNE MEDICAL BIOWICK SURELOCK ANCHOR 2.7MM; FASTENER, FIXATION

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during surgery when implanting an anchor, there was difficulty implanting the anchor.Additionally, the upper part of this complaint product's anchor came off, so the surgeon removed the anchor of this product from the patient's body.The remaining part of the device was successfully implanted.No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).Report source: foreign : japan.Concomitant medical products: part# cm-6127 biowick surelock anchor 2.7mm lot# 65223230.Part# cm-6101 drill biowick surelock 2.7mm lot# 79280-1.No product was returned or pictures of the product provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Device history records were reviewed and no discrepancies related to the reported event were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: BIOWICK SURELOCK ANCHOR 2.7MM
• Common Device Name: FASTENER, FIXATION
• Manufacturer (Section D): CAYENNE MEDICAL; 16597 n 92nd street; scottsdale AZ 85260
• Manufacturer (Section G): CAYENNE MEDICAL; 16597 n 92nd street; scottsdale AZ 85260
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15175312
• Report Number: 3006108336-2022-00024
• Device Sequence Number: 14720769
• Product Code: MBI
• UDI-Device Identifier: 00887868269769
• UDI-Public: (01)00887868269769(17)230310(10)65223230
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151068
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/04/2022

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 Expiration Date: 03/10/2023
• Device Model Number: N/A
• Device Catalogue Number: CM-6127
• Device Lot Number: 65223230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2022
• Initial Report FDA Received Date: 08/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Sex: Unknown