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	08/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported by the affiliate in (b)(6) that during an arthroscopy anterior cruciate ligament repair procedure on (b)(6) 2021, it was observed that the tip on the 4.5 longer tip beath pin device was broken.There were fragments generated; therefore, two x-rays were necessary to remove all the fragments.There was a surgical delay of 10 minutes.The status of the patient post-surgery was unknown.No additional information was provided.
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: investigation summary: according to the information received, it was reported that during an arthroscopy acl repair the tip of the rigid loop 4.5mm combo reamer/passing pin out of the rigid loop adjustable disposables kit was broken.The complaint device is not being returned, therefore unavailable for a physical evaluation.Since the complaint device was not returned, we cannot determine a root cause for the reported failure.If the device is received in the future, we will reopen the complaint and perform the investigation as appropriate.According with manufacturer, the lot number provided is not matching with the part number provided by the customer, therefore, the manufacturing record evaluation (mre) review cannot be performed.If the right lot number becomes available, the mre review will be performed.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.

• 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 (Section G): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 12439446
• Report Number: 1221934-2021-02654
• Device Sequence Number: 3873266
• Product Code: HWE
• UDI-Device Identifier: 10886705026494
• UDI-Public: 10886705026494
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2021

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: 04/30/2026
• Device Model Number: 232460
• Device Catalogue Number: 232460
• Device Lot Number: 8L17113
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2021
• Supplement Date Received by Manufacturer: 11/22/2021
• Initial Report FDA Received Date: 09/08/2021
• Supplement Report FDA Received Date: 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2021
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown