MAUDE Adverse Event Report: SYNTHES GMBH 4.5MM BROAD LCP PLATE 14 HOLES/260MM; PLATE, FIXATION, BONE

Model Number	226.641
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	02/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Hold rh 2.22.23 it was reported that surgeon revised a femur fracture on (b)(6) 2023 that failed.A locking screw appears to have possibly been put in a non locking hole and the plate pulled off the bone.One of the 5.0 locking screw was broken, and the shaft fragment remained in the patient.The hardware was placed in (b)(6) 2021.Additionally during this revision, the table top plate bender did not work properly because the screw that secures anvil would not screw in.It is currently unknown if the threads on the screw were damaged or threads on the plate bender.More information will be available after it is inspected post operatively.This report is for one (1) 4.5mm broad lcp plate 14 holes/260mm this is report 1 of 4 for complaint (b)(4).
Additional Manufacturer Narrative
Product complaint #: (b)(4).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.Complainant part is not expected to be returned for manufacturer review/investigation.Date of concomitant therapy is (b)(6) 2023.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.Device history lot: part #: 226.641, synthes lot #: 6952750, supplier lot #: n/a, release to warehouse date: may 30,2012, manufactured by: synthes elmira.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.

• Brand Name: 4.5MM BROAD LCP PLATE 14 HOLES/260MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16418065
• Report Number: 8030965-2023-02138
• Device Sequence Number: 3289459
• Product Code: HRS
• UDI-Device Identifier: 10886982159212
• UDI-Public: (01)10886982159212
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K082807
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/22/2023

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 Model Number: 226.641
• Device Catalogue Number: 226.641
• Device Lot Number: 6952750
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2023
• Initial Report FDA Received Date: 02/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2012
• 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: PLATE-BENDING PRESS; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING: TRAUMA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 127 KG