MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH ROD CUTTER 3.5 AND 4.0 RODS; INSTRUMENT, CUTTING, ORTHOPAEDIC

Model Number	2020-00-135
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent for a surgery.During the surgery, the rod cutter is broke.It was unknown how damaged happened.It was unknown if the surgery completed successfully.The patient outcome was unknown.Concomitant device reported: unknown symphony rod 4.0mm (part# unknown, lot# unknown, quantity unknown).This complaint involves one (1) device.This report is for (1) rod cutter 3.5 and 4.0 rods.This is report 1 of 1 for complaint (b)(4).
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.Visual inspection: the complaint device rod cutter 3.5 and 4.0 rods (product code: 202000135, lot number: gs741841) was returned to cq west chester for investigation.During visual inspection, one of the jaws of the cutter was found broken into two pieces.Device/defect identified: yes.Document /specification review: based on the date of manufacture, the current and manufactured version of the drawings were reviewed.103140293 rod cutter 3.4 and 4.0, 103267611 rev a (current and manufactured).Dimensional inspection: complaint relevant dimension cannot be measured due to the geometry of the device.Complaint confirmed: complaint can be confirmed based on the available information.Conclusion: the rod cutter had broken at its jaw.A definitive root cause was not determined during investigation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a review of the receiving inspection (ri) for rod cutter 3.5 and 4.0 rods was conducted identifying that lot number gs741841 was released in two batches.Batch1: lot qty of (b)(4) units were released on 30 apr 2020 with no discrepancies.Batch2: lot qty of (b)(4) units were released on 31 aug 2020 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Device history batch: null.Device history review: the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.

• Brand Name: ROD CUTTER 3.5 AND 4.0 RODS
• Common Device Name: INSTRUMENT, CUTTING, ORTHOPAEDIC
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 12861089
• Report Number: 1526439-2021-02457
• Device Sequence Number: 17295394
• Product Code: HTZ
• UDI-Device Identifier: 10705034530536
• UDI-Public: 10705034530536
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2021

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 Model Number: 2020-00-135
• Device Catalogue Number: 202000135
• Device Lot Number: GS741841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/27/2021
• Supplement Date Received by Manufacturer: 01/20/2022
• Initial Report FDA Received Date: 11/23/2021
• Supplement Report FDA Received Date: 01/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - RODS: SYMPHONY
• Patient Sex: Unknown