MAUDE Adverse Event Report: SYNTHES GMBH 4.5 VA-LCP CRVD COND PL/12 HOLE/266/LFT; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE

Model Number	02.124.413
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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.D2b.Additional pro-codes: hwc, hrs d9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j sales representative.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, the plate stripped during attachment of aiming arm with wrench.The operator was bent during process due to pressure.Rfna aiming arm was cracked during malleating.It is unknown if the procedure was completed successfully.There was no patient consequences.This complaint involves two (2) devices.This report is for one (1) 4.5 va-lcp crvd cond pl/12 hole/266/lft this is report 1 of 2 for complaint (b)(4).

• Brand Name: 4.5 VA-LCP CRVD COND PL/12 HOLE/266/LFT
• Common Device Name: IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16864597
• Report Number: 8030965-2023-05679
• Device Sequence Number: 20179848
• Product Code: JDP
• UDI-Device Identifier: 10886982042873
• UDI-Public: (01)10886982042873
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K110354
• 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 Model Number: 02.124.413
• Device Catalogue Number: 02.124.413
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2023
• Initial Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 4.2MM TROCAR 210MM; AIMING ARM RADIOLUCENT; REAMING ROD PUSH ROD 2.5MM SHAFT; REAMING ROD PUSH ROD 2.5MM SHAFT; UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: TRAUMA; UNK - WRENCHES: TRAUMA
• Patient Sex: Unknown