MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL COMBO BEATH PIN EA; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	232453
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: e3: reporter is a j&j sales representative.H4: the device manufacture date is currently unavailable.(b)(4) as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported by the sales rep that during a bridge enhanced anterior cruciate ligament repair procedure on (b)(6)2024, the combo beath pin ea device tip was broken off while drilling femoral tunnel.It was reported that a new pin was opened and the tunnel was redrilled to complete the procedure.There was a ten minute delay in the procedure reported.There were no adverse patient consequences reported.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.Device was used for treatment, not diagnosis.H10 additional narrative: d4, h4: the device manufacture date and expiration date were unavailable in the initial medwatch report.The device manufacture date and expiration date has been identified and updated accordingly.Investigation summary = > the device associated with this report was returned to depuy synthes mitek for evaluation.¿ upon visual inspection revealed that the combo beath pin ea was broken near the tip.Also foreign matter was found on the tip, presumable biological matter.The overall complaint was confirmed as the observed condition of the combo beath pin ea would have contributed to the complained issue.The manufacturer performed an investigation with the following results: an in-progress control has been performed on 9 parts chosen randomly by a certified operator and have been inspected.The result of this process check is successful, none of the 9 parts were non-conforming.The batches have been assembled by operators trained and certified on the process validated in production.A training verification has been performed at the moment in the production where the issue could have occurred.Every employee has completed the training for the processes.Effect of having a tip broken off for product code 232453 has been evaluated by combining probability and severity levels.Complaint (this complaint) has been received over 11803 parts produced since 2017 for having a tip break off while drilling femoral tunnel.With a ratio of 0.0085% < 0.02% and is ranking 1(=improbable and negligible), this risk is acceptable.1 nr was found during search between 2017-2024 with the item.0 nr for the same defect.The analysis showed that the production controls implemented must guarantee 100% detection of this type of problem if it was generated in neuchâtel.Multiple 100% control, guarantee that this type of defect does not occur in the manufacturing process.It can be concluded that it is highly unlikely that these defects were generated during the manufacturing process.Multiple controls 100% and in-process control ensures that manufactured products meet design specifications.Based on the above, it is confirmed that the manufacturing process was performed in accordance with the validated process.As per additional information from the manufacturer, the engraved number for device 232453 refers to the traceability of the component supplier, not the traceability of finished product.Device history record review: a device history record review was performed which indicated that there was a non-conformance unrelated to the reported malfunction.All the issues identified were resolved prior to product release.Based on the investigation findings, the potential cause is traced to the procedural variables, such handling of the device or product interaction during procedure.As per ifu, inspect for damage prior to use.Replace a damaged, worn, or bent instrument.Do not attempt to sharpen, straighten, or repair, and it has been determined that no corrective and/or preventative action is required.As part of depuy synthes mitek quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Correction: d4: the device lot number was reported as 2309001 in the previous report.The lot number has been updated to 240l050.Udi: (b)(6).
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: d9, h3, h6: the actual device has been returned and is currently pending evaluation.Once the device has been evaluated, a supplemental medwatch report will be sent accordingly.

• Brand Name: COMBO BEATH PIN EA
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA ; 3035526892
• MDR Report Key: 18795854
• Report Number: 1221934-2024-00593
• Device Sequence Number: 7144109
• Product Code: HWE
• UDI-Device Identifier: 10886705024544
• UDI-Public: 10886705024544
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 02/28/2024

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 Catalogue Number: 232453
• Device Lot Number: 240L050
• 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: 02/20/2024
• Supplement Date Received by Manufacturer: 03/07/2024; 03/08/2024; 03/21/2024; Not provided
• Initial Report FDA Received Date: 02/28/2024
• Supplement Report FDA Received Date: 03/08/2024; 03/11/2024; 04/08/2024; 04/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2023
• 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