MAUDE Adverse Event Report: CAYENNE MEDICAL 2.9MM GL HARD BONE DRILL; BIT, DRILL

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 that during shoulder arthroscopy, the tip of the juggerknot 2.9 drill broke and the tip remained in the patient.The juggerknot 2.9 anchor was successfully implanted, but the procedure was significantly extended - approximately over 30 minutes.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.The following sections were updated/corrected.Root cause attributed to use error as device was opened from its sterile packaging and placed into loaner kit.An issue evaluation was created to look further into this event.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D10 : part# 912020 juggerknot double loaded lot# 0002264389.Part# 912020 juggerknot double loaded lot# p15466.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Review of the device history records identified no deviations or anomalies during manufacturing.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.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual inspection confirms that the drill bit is fractured completely and the fractured piece was not returned for evaluation.The fracture occurred just after the beginning of the drill flutes.The rest of the device has cosmetic scratches and slight wear marks near the collar.Fracture surface analysis performed using sem on the hard bone drill sample showed that is suspected to have fractured due to reverse bending overload.Sem micrographs of the fracture surface showed two possible two crack initiation sites diagonal to one-another.Suspected two crack initiation sites identified at two corners of the sample showed signs of smearing, likely due to post fracture damage.Overload mode of fracture identified in the non-smeared areas of the fracture exhibiting ductile dimples.Previous root cause remains unchanged.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: 2.9MM GL HARD BONE DRILL
• Common Device Name: BIT, DRILL
• 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: 12488403
• Report Number: 3006108336-2021-00040
• Device Sequence Number: 19841194
• Product Code: HTW
• UDI-Device Identifier: 00887868270345
• UDI-Public: (01)00887868270345(17)230226(10)71094-2
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/20/2022

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: 02/26/2023
• Device Model Number: N/A
• Device Catalogue Number: CM-9324ST
• Device Lot Number: 71094-2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 09/10/2021
• Supplement Date Received by Manufacturer: 01/20/2022; 02/09/2022; 10/06/2021
• Initial Report FDA Received Date: 09/17/2021
• Supplement Report FDA Received Date: 01/25/2022; 02/18/2022; 10/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.; UNKNOWN JUGGERKNOT 2.9.; UNKNOWN JUGGERKNOT 2.9
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Sex: Unknown