MAUDE Adverse Event Report: SYNTHES TRAUMA : ORTHOSPIN MAXFRAME AUTOSTRUT(TM)HEXAPOD STRUT-SHRT; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	1100012-01
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2023
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.H10 additional narrative: d2b.Additional pro-codes: osn.D3: county code: israel.D3: manufacturer postal code 2066720.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.E3: reporter is a j&j sales representative.H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.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 may 4.2023 the max-frame struts were not moving appropriately.No patient consequences was reported.This complain involves three (3) devices.This report is for one (1) maxframe autostrut(tm)hexapod strut-shrt this is report 3 of 3 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.H10 additional narrative: h4: part:1100012-01, lot:2109300099, manufacturing site: orthospin, supplier: na, release to warehouse date: 24 jun 2022, expiration date: na.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified 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.

• Brand Name: MAXFRAME AUTOSTRUT(TM)HEXAPOD STRUT-SHRT
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SYNTHES TRAUMA : ORTHOSPIN; 13 hayezira st.; yoqneam ; IS
• Manufacturer Contact: oren cohen ; 13 hayezira st.; yoqneam, PA 20667-20 ; IS 2066720 ; 3035526892
• MDR Report Key: 16968649
• Report Number: 3015781803-2023-00017
• Device Sequence Number: 12068414
• Product Code: KTT
• UDI-Device Identifier: 10886982338594
• UDI-Public: (01)10886982338594
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K202810
• 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,Followup
• Report Date (Section B): 05/19/2023

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: 1100012-01
• Device Catalogue Number: 1100012-01
• Device Lot Number: 2109300099
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/04/2023
• Supplement Date Received by Manufacturer: 06/12/2023
• Initial Report FDA Received Date: 05/19/2023
• Supplement Report FDA Received Date: 06/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2022
• 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: MAXFRAME AUTOSTRUT(TM)HEXAPOD STRUT-SHRT.; MAXFRAME AUTOSTRUT(TM)HEXAPOD STRUT-SHRT.
• Patient Sex: Male