MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 95 DEG CONDYLAR PLATE 9 HOLES/70MM/156MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT

Model Number	237.94
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event occurred on an unknown date in 2021.Complainant part is not expected to be returned for manufacturer review/investigation.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
It was reported that the patient underwent revision surgery on (b)(6) 2021 due to incomplete union and/or trauma resulting in a fracture of the bone and a broken blade plate.The surgeon removed the broken blade plate/screws, cleaned out the fracture site, and inserted a tfna nail after reducing the fracture.It is unknown when the original surgery was performed.There is no further information available.This report is for one (1) 95 deg condylar plate 9 holes/70mm/156mm.This is report 1 of 1 for (b)(4).
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.Part: 237.940-us lot: 22p5747 manufacturing site: grenchen.Release to warehouse date: november 22, 2019.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Investigation summary: the complaint device (95 deg condylar plate 9 holes/70mm/156mm) was not received for investigation.A photo investigation was performed based on the photo.The image was reviewed, and the complaint condition is confirmed.A plate and screw construct is visible at the left femur, the plate appears to be broken across the second hole from top to bottom.A non union fracture is also seen on the breakage section.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 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: 95 DEG CONDYLAR PLATE 9 HOLES/70MM/156MM
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK GRENCHEN (CH); solothurnstrasse 186; grenchen 2540 ; SZ 2540
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13366560
• Report Number: 2939274-2022-00252
• Device Sequence Number: 12094296
• Product Code: KTW
• UDI-Device Identifier: 10886982161611
• UDI-Public: 10886982161611
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K914546
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• 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,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 Model Number: 237.94
• Device Catalogue Number: 237.94
• Device Lot Number: 22P5747
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/29/2021
• Supplement Date Received by Manufacturer: 02/03/2022
• Initial Report FDA Received Date: 01/27/2022
• Supplement Report FDA Received Date: 02/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2019
• 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: 4.5MM CORTEX SCREW 32MM; 4.5MM CORTEX SCREW 32MM; 4.5MM CORTEX SCREW 32MM; 4.5MM CORTEX SCREW 32MM; 4.5MM CORTEX SCREW 32MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female