MAUDE Adverse Event Report: SYNTHES GMBH PEDIATRIC LCP HIP PLATE 5.0MM/130°/5 HOLES-STERILE; PLATE, FIXATION, BONE

Catalog Number	02.108.341S
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Pain (1994); Insufficient Information (4580)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
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: b3: event occurred on an unknown date in 2023.D2: additional procode: hwc.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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
Device report from australia reports an event as follows: it was reported that on an unknown date, the lcp in question broke.Partially weight bearing post-surgery.On (b)(6) 2023, the patient underwent a procedure to revise with an im nail.The revision procedure was completed successfully.There is no additional information available to report.This report is for a pediatric lcp hip plate 5.0mm/130°/5 holes-sterile.This is report 1 of 1 for (b)(4).
Event or Problem Description
It was further reported the patient was revised due to plate breakage on (b)(6)2023.(b)(6)2023 was confirmed as explant date.Breakage was determined by x-ray.Post-op patient reports pain.
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.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned device found that the lcp paed-hippl5 130° w/23 l111 was broken in two pieces, the broken fragment was returned for evaluation, also signs of worn were observed.A dimensional inspection for the lcp paed-hippl5 130° w/23 l111 was unable to be performed due to post manufacturing damage.The overall complaint was confirmed as the observed condition of the lcp paed-hippl5 130° w/23 l111 would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition ¿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.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Device history review (dhr): a manufacturing record evaluation was performed for the finished device (part # 02.108.341s lot # 838p698) and no non-conformances / manufacturing irregularities 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.
Event or Problem Description
Date of implant was reported to be (b)(6)2023.
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 information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
These were explanted with the plate.There was no allegation against the screws.
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.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: PEDIATRIC LCP HIP PLATE 5.0MM/130°/5 HOLES-STERILE
• Common Device Name: PLATE, FIXATION, BONE
• 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: 17441878
• Report Number: 8030965-2023-09656
• Device Sequence Number: 11441235
• Product Code: HRS
• UDI-Device Identifier: 10886982029966
• UDI-Public: (01)10886982029966
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K112085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 02.108.341S
• Device Lot Number: 838P698
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/17/2023
• Supplement Date Received by Manufacturer: 08/03/2023; 09/15/2023; 10/13/2023; 01/09/2024
• Initial Report FDA Received Date: 08/02/2023
• Supplement Report FDA Received Date: 08/17/2023; 09/25/2023; 10/13/2023; 01/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2022
• 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: CORTSCR Ø4.5 SELF-TAP L34 SST; CORTSCR Ø4.5 SELF-TAP L34 SST; CORTSCR Ø4.5 SELF-TAP L36 SST; CORTSCR Ø4.5 SELF-TAP L42 SST; LOCKSCR Ø5 SELF-TAP L65 SST; LOCKSCR Ø5 SELF-TAP L85 SST; LOCKSCR Ø5 SELF-TAP L85 SST
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female