MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM VA-LCP CURVED CONDYLAR PLATE/16 HOLE/336MM/RIGHT; IMPLANT,FIXATION DEVICE, CONDYLAR PLATE

Model Number	02.124.416
Medical Device Problem Codes	Crack (1135); Material Deformation (2976)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/ investigation.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.(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 or Problem Description
It was reported that on (b)(6) 2019, the patient went a revision of a peri prosthetic femur fracture, a right variable angle (va) condylar plate was cracked and deformed.Plates and screws were removed and the fracture was not healed.It was revised into a new right variable angle (va) plate with 16 holes.The stem of the total hip was replaced to a longer stem that crossed the original fracture.The procedure outcome and patient status were unknown.Concomitant device reported: unknown screws (part # unknown, lot # unknown, quantity unknown).This complaint involves one (1) device.This is 1 of 1 for report (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: b5, d4, d11.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
Concomitant devices: va locking screw l75mm (part #: 02.231.275, lot #: 4l36645, quantity: 2), va locking screw l75mm (part #: 02.231.275, lot #: 4l97581, quantity: 1), va locking screw l70mm (part #: 02.231.270, lot #: 2l86783, quantity: 1), va locking screw l70mm (part #: 02.231.270, lot #: 4l84078, quantity: 1), va locking screw l60mm (part #: 02.231.260, lot #: 2522949, quantity: 1), va locking screw l38mm (part #: 02.231.238, lot #: 4l72601, quantity: 1), va locking screw l38mm (part #: 02.231.238, lot #: 4l92506, quantity: 1), va locking screw l34mm (part #: 02.231.234, lot #: unk, quantity: 1), va locking screw l16mm (part #: 02.231.016, lot #: l773486, quantity: 1) and unknown screw (part #: unknown, lot #: unknown, quantity: 1).
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.H3, h6: investigation summary.Investigation flow: damage.Visual inspection: the 4.5 mm va-lcp curved condylar plate/16 hole/336 mm/right (p/n: 02.124.416, lot #: 3l68697) was returned and received at us cq.Upon visual inspection, it was observed that the plate was bent and was cracked on both sides near the va-7 and va-8 holes.There were scratches on the device but has no impact on the functionality of the device.No other defects were identified with the returned device.Device failure/defect identified? yes.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Furthermore, the complaint relevant dimensions cannot be checked for dimensional accuracy, because of the design of the device.Document/specification review: based on the date of manufacture, reflecting the current and manufactured revision were reviewed.Complaint confirmed? yes, the device received was cracked and bent.Hence confirming the allegation.Investigation conclusion: the complaint condition is confirmed for the 4.5 mm va-lcp curved condylar plate/16 hole/336 mm/right (p/n: 02.124.416, lot #: 3l68697).There is no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.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.Device history lot.Part: 02.124.416.Lot: 3l68697.Manufacturing site: mezzovico.Release to warehouse date: mar.07, 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: 4.5MM VA-LCP CURVED CONDYLAR PLATE/16 HOLE/336MM/RIGHT
• Common Device Name: IMPLANT,FIXATION DEVICE, CONDYLAR PLATE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9316833
• Report Number: 2939274-2019-62155
• Device Sequence Number: 18984191
• Product Code: JDP
• UDI-Device Identifier: 10886982042934
• UDI-Public: (01)10886982042934
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K110354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/28/2019

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: 02.124.416
• Device Catalogue Number: 02.124.416
• Device Lot Number: 3L68697
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2020
• Initial Date Received by Manufacturer: 10/28/2019
• Supplement Date Received by Manufacturer: 02/19/2020; 03/04/2020
• Initial Report FDA Received Date: 11/13/2019
• Supplement Report FDA Received Date: 02/19/2020; 03/05/2020
• Patient Sequence Number: 0
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: TRAUMA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 86 YR