MAUDE Adverse Event Report: SYNTHES GMBH 3.5MM LCP RECONSTRUCTION PLATE 6 HOLES/84MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number 245.061

Device Problem Material Deformation (2976)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/03/2021

Event Type  Injury  

Manufacturer Narrative

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.(b)(4).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 synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent a corrective procedure 2 weeks after initial surgery because the plate was not seated correctly and needed revision.Upon operating and removing the plate, it was discovered that the plate was significantly bent.The procedure was completed successfully.This report is for one (1) 3.5mm lcp reconstruction plate 6 holes/84mm.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

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.H10 additional narrative: h6 - codes updated to imdrf codes.Investigation summary: the complaint device (lcp recopl 3.5 straight w/combined hole was not received for investigation.A photo investigation was performed based on the photos attached in notes & attachments section of pc titled ¿(b)(4) - depuy synthes complaint - 245.061".Reviewing the evidence provided the reported event cannot be confirmed.After review of the photo provided it can be visually detected that the device is lightly bent, but, according to the surgical technique "lcp small fragment technique guide" (dsus/trm/1016/1165 rev 2 11/19), this product design is intended to be bent in order to adapt it to the anatomy of the patient during procedure, there is no evidence available to prove that the current state of the plate is not intentional.A definite assignable root cause could not be determined based on the provided information.As the device was not returned, and as-received condition could not be assessed and a dimensional inspection and document/specification review were not completed.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot - part #: 245.061 lot #: 6l06019 manufacturing site: werk raron release to warehouse date: 06 sep 2019 a manufacturing record evaluation was performed for the finished device lot number, 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: 3.5MM LCP RECONSTRUCTION PLATE 6 HOLES/84MM
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK RARON (CH); kanalstrasse west 30; raron 3942 ; SZ 3942
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 13153306
• MDR Text Key: 283162583
• Report Number: 8030965-2022-00027
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 07611819242531
• UDI-Public: (01)07611819242531
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K000684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• 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

• Date FDA Received: 01/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 245.061
• Device Lot Number: 6L06019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - SCREWS: TRAUMA
• Patient Outcome(s): Required Intervention
• Patient Age: 14 YR