MAUDE Adverse Event Report: SYNTHES GMBH REAMING ROD PUSH ROD 2.5MM SHAFT; REAMER

Catalog Number	SD03.010.093
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #(b)(4).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.H11 additional narrative: e3: reporter is a j&j sales representative.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6: without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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
It was reported that on an unknown date during a nonunion humerus, the humerus was ria¿d.During ria surgeon put stimulan in the canal, the cement clogged the ria 2 shafts.Both the instruments in the set were used.Both filled with cement.The surgeon tried to push the sd operator through and they both bent and broke off.Multiloc graphic cases and ria 2 graphic cases were splattered with cement and unable to be remove.There was no patient consequences.This report is for one (1) reaming rod push rod 2.5mm shaft.This is report 3 of 4 for complaint (b)(4).

• Brand Name: REAMING ROD PUSH ROD 2.5MM SHAFT
• Common Device Name: REAMER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 19367159
• Report Number: 8030965-2024-06560
• Device Sequence Number: 6499895
• Product Code: HTO
• UDI-Device Identifier: 10886982002570
• UDI-Public: (01)10886982002570
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: SD03.010.093
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DRIVE SHAFT FOR RIA 2 520MM.; GC FOR MULTILOC HUM NL INST SET.; GC FOR MULTILOC PROX HUM NL INST SET.; GRAPHIC CASE LID RIA 2 INSTRUMENT SET.; GRAPHIC CASE LID RIA 2 INSTRUMENT SET.; REAMING ROD PUSH ROD 2.5MM SHAFT.; REAMING ROD PUSH ROD 2.5MM SHAFT.; UNK CEMENT.
• Patient Sex: Unknown