MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC VA-LCP DHP 2.7/3.5 MED W/EXT LE MED 2HO; PLATE, FIXATION, BONE

Model Number	02.117.702
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Unknown patient identifier no weight provided.Date of plate breakage is unknown.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 a patient was initially treated for an intra-articular distal humerus fracture on (b)(6) 2018 with 2.7/3.5mm variable angle (va) locking compression plate (lcp) medial and lateral distal humerus plates.The patient had a subsequent plate breakage of the 2.7/3.5mm va lcp medial distal humerus plate and was brought to the operating room on (b)(6) 2018 for revision surgery.The surgery on (b)(6) 2018 involved removal of the broken plate and five screws, and was revised to a longer 2.7/3.5mm va lcp medial distal humerus plate and an additional 2.7/3.5mm va lcp posteromedial distal humerus plate.Concomitant devices reported: screws (part # 02.111.042, lot # unknown, quantity 1), screws (part # 02.111.038, lot # unknown, quantity 1), screws (part # 02.111.040, lot # unknown, quantity 1), screws (part # 204.826, lot # unknown, quantity 1), screws (part # 204.828, lot # unknown, quantity 1).This complaint involves one device.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.A device history record review was performed for the subject device: part no.: 02.117.702 , lot no.: l549688 , manufacturing location: mezzovico , release to warehouse date: 29.Aug.2017.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.A product development investigation was performed for the subject device: customer quality investigation: at customer quality, the returned va-lcp plate (part: 02.117.702, lot: l549688, mfg: 29-aug-2017) was inspected and the complaint was confirmed.The following investigations were performed: broken: visual inspection performed at customer quality observed plate breakage at its second threaded hole from the end of the plate.No issues were identified with the remaining portions of the device.The received condition agree with the complaint description and the complaint was confirmed.Relevant drawings for the returned device were reviewed (both current and from the time of manufacture): top-level drawing for va-lcp medial distal humerus plate,02_117_401.Due to the complex curvatures of the plate accurate dimensional inspection at the broken portion was not able to be performed.However, the dimensional analysis performed on the thickness of the plate at the broken region measured 2.77 mm(ca-814) that falls within the specifications of 2.75 mm (+ 0.1/0.2) per the closest cross-section.During investigation, dhr reviewer was contacted to get confirmation on the material review and it was confirmed from the dhr reviewer that the material check performed during dhr review observed no issues with material and its properties that could have contributed to this complaint condition.A device history review performed for the returned implant lot number showed no ncrs that would contribute to this complaint condition were generated during production.Dcrm review performed showed that the distal humerus plates - core dossier design and clinical risk management (dcrm) document addressed the complaint condition.While no definitive root cause could be determined, it is likely that any unintended forces encountered by the device during patient¿s post-op activities could have contributed to the broken device condition.During the investigation, no product design or manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: VA-LCP DHP 2.7/3.5 MED W/EXT LE MED 2HO
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7506522
• Report Number: 2939274-2018-52137
• Device Sequence Number: 13799326
• Product Code: HRS
• UDI-Device Identifier: 10886982037183
• UDI-Public: (01)10886982037183
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K120070
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2018

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: No Information
• Device Model Number: 02.117.702
• Device Catalogue Number: 02.117.702
• Device Lot Number: L549688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2018
• Initial Date Received by Manufacturer: 04/18/2018
• Supplement Date Received by Manufacturer: 06/15/2018
• Initial Report FDA Received Date: 05/11/2018
• Supplement Report FDA Received Date: 06/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR