MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM/3.5MM VA-LCP EXT MEDL DSTL HUM PL 4H/LT/111MM-LONG; PLATE,FIXATION,BONE

Model Number	02.117.704
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Unknown date in 2018.(b)(4).Device history lot part: 02.117.704.Lot: l456371.Manufacturing site: (b)(4).Release to warehouse date: 22.Jun.2017.The device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.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 a revision procedure on an unknown date in 2018.A broken distal humerus plate, an unknown 3.5 cortex screw, two (2) 3.5 locking screws, and four (4) variable angle locking screws were removed successfully.The original surgery date was on (b)(6) 2018.Surgical outcome and patient outcome are unknown.Concomitant devices reported: unknown cortex screw (part# unknown, lot# unknown, quantity 1).Unknown 3.5mm locking screws (part# unknown, lot# unknown, quantity 2).Unknown 2.7mm variable-angle (va) locking screws (part# unknown, lot# unknown, quantity 4).This report is for one (1) 2.7mm/3.5mm va-lcp ext medl dstl hum pl 4h/lt/111mm-long.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.Additional product code: hwc.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: 2.7MM/3.5MM VA-LCP EXT MEDL DSTL HUM PL 4H/LT/111MM-LONG
• 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: 8150982
• Report Number: 2939274-2018-55347
• Device Sequence Number: 1569618
• Product Code: HRS
• UDI-Device Identifier: 10886982037220
• UDI-Public: (01)10886982037220
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K120070
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2018

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: Health Professional
• Device Model Number: 02.117.704
• Device Catalogue Number: 02.117.704
• Device Lot Number: L456371
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/20/2018
• Supplement Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 12/11/2018
• Supplement Report FDA Received Date: 12/11/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 25 YR
• Patient Weight: 84