MAUDE Adverse Event Report: SYNTHES GMBH TI LCP(TM) DISTAL FEMUR PLATE 11 HOLES/276MM-LEFT; PLATE, FIXATION, BONE

Catalog Number 422.257

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Metal Related Pathology (4530); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/05/2022

Event Type  Injury  

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.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 Description

Device report from switzerland reports an event as follows: it was reported that patient underwent revision surgery on (b)(6) 2022, to remove plates and screws.The devices were implanted nine months prior.The surgeon noticed a strong metallosis.This report is for a titanium (ti) locking compression plate (lcp) distal femur plate 11 holes/276mm-left.This is report 1 of 2 for (b)(4).

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: d4, h4: the lot number and device manufacture date were reported as unknown on the initial report; and have been updated accordingly.D9, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

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.

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.A manufacturing record evaluation was performed for the finished device lot and no non-conformance was identified.Part #: 422.257, lot #: 19p2466, manufacturing site: jabil grenchen, release to warehouse date: 18, october 2019.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 sample revealed that there was no damage or defects with the lcp-df 4.5/5 le 11ho l276 tan.The device appears to be in good condition only with light scratches most likely made during removal of the implant.A scanning electron microscope (sem) test was performed on the complaint device.The images were generated with the sem by scanning the surface with a focused beam of electrons.The electrons interacted with the atoms of the sample producing signals about the topography and composition.The sample composition was identified using energy dispersive spectroscopy (eds).The sample was stimulated with an energy beam charged of electrons to emit characteristic x rays from the elements.The characteristic x rays were separated into an energy spectrum to determine the elements abundance based on the peaks of the electromagnetic emission from the atomic structure of the element.Sem analysis was performed.There was evidence of mechanical damage on product 422.257.There was not found oxidation on the damage, due to is a higher percentage of oxygen in the coating than in the damage.The damage could be related to the handling of the device during the procedure; however, this cannot be conclusively determined.No other anomalies were observed.A dimensional inspection for the lcp-df 4.5/5 le 11ho l276 tan was not performed since it is not applicable to the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the lcp-df 4.5/5 le 11ho l276 tan was found to have no damage or defects.No definitive root cause could be determined.There was no indication that a design or manufacturing issue contributed to the complaint.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.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TI LCP(TM) DISTAL FEMUR PLATE 11 HOLES/276MM-LEFT
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK GRENCHEN (CH); solothurnstrasse 186; grenchen 2540 ; SZ 2540
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15141110
• MDR Text Key: 297004052
• Report Number: 8030965-2022-05472
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819287938
• UDI-Public: (01)07611819287938
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K062564
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• 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

• Date FDA Received: 08/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 422.257
• Device Lot Number: 19P2466
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: CANNSCR ø4 SELF-DRILL L50/16 TAN GOLD; CANNSCR Ø4 SELF-DRILL L30/10 TAN GOLD; CORTSCR Ø4.5 L46 TI; CORTSCR Ø4.5 L46 TI; CORTSCR Ø4.5 SELF-TAP L30 TI; CORTSCR Ø4.5 SELF-TAP L34 TI; LCP 4.5/5 NARROW 11HO L206 TI; LOCKSCR Ø5 SELF-TAP L18 TAN; LOCKSCR Ø5 SELF-TAP L30 TAN; LOCKSCR Ø5 SELF-TAP L32 TAN; LOCKSCR Ø5 SELF-TAP L32 TAN; LOCKSCR Ø5 SELF-TAP L36 TAN; LOCKSCR Ø5 SELF-TAP L40 TAN; LOCKSCR Ø5 SELF-TAP L80 TAN; LOCKSCR Ø5 SELF-TAP L80 TAN; UNK - SCREWS: TRAUMA
• Patient Outcome(s): Required Intervention