MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL 4.5 LONGER TIP BEATH PIN; CANNULATED SURGICAL DRILL

Model Number	232460
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the affiliate in (b)(6) that during an anterior cruciate ligament reconstruction surgery on (b)(6) 2022, it was observed that the 4.5 longer tip beath pin device broke.There were no fragments generated.Another like device was used to complete the procedure with a delay of five minutes.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.D4: the lot/serial number was reported as unknown on the initial report; and has been updated accordingly.Udi: (b)(4).The lot was unknown.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: h4: the device manufacture date was reported as unknown on the initial report; and has been updated accordingly.Investigation summary: the product was returned to mitek for evaluation.Mitek then conducted visual inspection of device received and photo provided by the customer.The device was received and evaluated in westchester.The tip of the device was broken.The complaint reported was confirmed.The photo provided by the customer showed the broken condition.A manufacturing record evaluation was performed for the finished device lot number:5l35681, and no nonconformances were identified.The possible root cause can be attributed when the device being mishandled on hard surface with heavily force causing breakage.Besides, possibility of mishandling, we cannot discern a root cause for this failure mode.As per ifu, inspect the instruments before use for integrity and compatibility in order to ensure proper functionality and safety.Place the instrument in the appropriate location within the sterilization tray.During the cleaning process, inspect the instruments after each cleaning cycle to ensure proper functionality function and safety.If you suspect a problem, set aside the instrument for repair.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by depuy mitek or its employees that the report constitutes an admission that the device, depuy mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as apropriate.H10 additional narrative: investigation summary the product was returned to mitek for evaluation.Mitek then conducted visual inspection of device received and photo provided by the customer.The device was received and evaluated.It was determined that the tip of the device was broken.The complaint reported was confirmed.The photo provided by the customer showed the broken condition.A manufacturing record evaluation was performed for the finished device lot number: 5l35681, and no nonconformances were identified.The possible root cause can be attributed when the device being mishandled on hard surface with heavily force causing breakage.Besides, possibility of mishandling, we cannot discern a root cause for this failure mode.As per ifu, inspect the instruments before use for integrity and compatibility in order to ensure proper functionality and safety.Place the instrument in the appropriate location within the sterilization tray.During the cleaning process, inspect the instruments after each cleaning cycle to ensure proper functionality function and safety.If you suspect a problem, set aside the instrument for repair.

• Brand Name: 4.5 LONGER TIP BEATH PIN
• Common Device Name: CANNULATED SURGICAL DRILL
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle CH-24-00 ; SZ CH-2400 ; 6013142063
• MDR Report Key: 13252805
• Report Number: 1221934-2022-00169
• Device Sequence Number: 4584827
• Product Code: HWE
• UDI-Device Identifier: 10886705026494
• UDI-Public: 10886705026494
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup

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: 06/30/2022
• Device Model Number: 232460
• Device Catalogue Number: 232460
• Device Lot Number: 5L35681
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2022
• Supplement Date Received by Manufacturer: 03/04/2022; 04/07/2022; 05/23/2022; 05/27/2022
• Initial Report FDA Received Date: 01/13/2022
• Supplement Report FDA Received Date: 03/07/2022; 04/08/2022; 05/25/2022; 05/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2019
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown