MAUDE Adverse Event Report: CAYENNE MEDICAL QUATTRO X ANCHOR 5.5 BB TAPENS; 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	04/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: pn cm-9011 ln 77971-1 quattro suture passer needle.Pn cm-9155 ln 77236-2 quattro link anchor 5.5mm.Report source: foreign: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported during an initial rotator cuff reconstruction, after puncturing the bone, the anchor was inserted into the tissue and then gently tapped on the anchor inserter.Then the operator started screwing the anchor, but the anchor did not screwed in that is why the operator pulled out the inserter few times and the anchor was broke.All components were removed from the patient.Another anchor with the same lot was used without further complications.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified that the product was returned with minimal signs of use aside from the fractured anchor.The anchor is in place at the end of the sutures but was not seated on the inserter tip.The anchor is fractured completely but both pieces were retained on the sutures.The anchor threads show slight flaring.The base of the anchor and the inserter tip show no signs of damage or deformities.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot 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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: QUATTRO X ANCHOR 5.5 BB TAPENS
• Common Device Name: FASTENER, FIXATION
• Manufacturer (Section D): CAYENNE MEDICAL; 16597 n 92nd street; scottsdale AZ 85260
• MDR Report Key: 11869540
• Report Number: 3006108336-2021-00022
• Device Sequence Number: 13683408
• Product Code: MBI
• UDI-Device Identifier: 00887868270949
• UDI-Public: (01)00887868270949(17)250114(10)74323-2
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K112814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2021

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 Expiration Date: 01/14/2025
• Device Model Number: N/A
• Device Catalogue Number: CM-9255BG
• Device Lot Number: 74323-2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/29/2021
• Supplement Date Received by Manufacturer: 07/22/2021
• Initial Report FDA Received Date: 05/24/2021
• Supplement Report FDA Received Date: 07/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10