MAUDE Adverse Event Report: SYNTHES GMBH LCP-DF 4.5/5 R 13HO L316 SST; PLATE, FIXATION, BONE

Catalog Number 222.258

Device Problem Break (1069)

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional narrative: 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 synthes reports an event in the (b)(6) as follows: i have spoken to one of the customers today who has informed me that a distal femoral plate (code / lot number unknown at this point) has failed.Breaking around the distal 3rd of the plate between the combi hole.The plate was originally implanted in (b)(6) 2021 however the exact date is unknown.The revision surgery was successfully performed today with a competitor distal femoral plate.The patient femur was in a state of non-union.This complaint involves one(1) device lcp-df 4.5/5 r 13ho l316 sst.This is report 1 of 1 for complaint (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.H3, h6: a product investigation was conducted.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 lcp-df 4.5/5 r 13ho l316 sst was was found to be broken in two section across to one of the combi hole.A dimensional inspection for the lcp-df 4.5/5 r 13ho l316 sst was unable to be performed due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the lcp-df 4.5/5 r 13ho l316 sst would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.A device history record (dhr) review was conducted: product code: 222.258, lot number: 68p0551, manufacturing site: mezzovico , release to warehouse date: 10 sept 2020.A manufacturing record evaluation was performed for the not sterile 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: LCP-DF 4.5/5 R 13HO L316 SST
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14875810
• MDR Text Key: 295051276
• Report Number: 8030965-2022-04507
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819189164
• UDI-Public: (01)07611819189164
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K062564
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 222.258
• Device Lot Number: 68P0551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2020
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention