MAUDE Adverse Event Report: SYNTHES GMBH 3.5MM LOCKING SCREW SELF-TAPPING 24MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number	213.024
Medical Device Problem Codes	Device-Device Incompatibility (2919); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from synthes reports an event in france as follows: it was reported that on (b)(6) 2024, in the pediatric surgical operating room, it was observed after a varization osteotomy in a paraplegic child not walking, a balling hip reflecting a rupture of the 2 proximal lcp 3.5 screws used to place an lcp 3.5 plate.The screw head lock was still in place.The patient had to undergo a new operation of 2 hours to refit a new plate using screws of different references, including the one in question.This report involves one (1) 3.5mm locking screw self-tapping 24mm.This is report 4 of 4 for (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.H10 additional narrative: d9: complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).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.
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.B1, b5, h1, h6: the initial complaint was reviewed and found not reportable.Upon further review it was determined that there is no allegation against this device.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
Upon further review it was determined that there is no allegation against this device.

• Brand Name: 3.5MM LOCKING SCREW SELF-TAPPING 24MM
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• 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: 19593768
• Report Number: 8030965-2024-07808
• Device Sequence Number: 14448135
• Product Code: KTT
• UDI-Device Identifier: 10886982153098
• UDI-Public: (01)10886982153098
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K000684
• 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

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: 213.024
• Device Lot Number: 4282P05
• 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: 06/24/2024
• Supplement Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 06/24/2024
• Supplement Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2023
• 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: LCP PAED-HIPPL 3.5 100° W/19 L73; LCP PAED-HIPPL 3.5 110° W/19 L73; LOCKSCR Ø3.5 SELF-TAP L18 SST; LOCKSCR Ø3.5 SELF-TAP L20 SST; LOCKSCR Ø3.5 SELF-TAP L24 SST; LOCKSCR Ø3.5 SELF-TAP L50 SST; LOCKSCR Ø3.5 SELF-TAP L50 SST
• Patient Sex: Unknown