MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM NARROW LCP® PLATE 6 HOLES/116MM; PLATE, FIXATION, BONE

Model Number	224.561
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional device product codes: hwc, ktt.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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.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 underwent right distal humerus revision surgery due to non-union and broken plate.The patient was originally implanted with the following devices on an unknown date; one (1) 4.5mm/16mm narrow locking compression plate (lcp) with 6 holes, two (2) 4.5 mm/ 32mm cortex screw self-tapping, one (1) 4.5mm/36mm cortex screw self-tapping, one (1) 5.0mm/28mm locking screw self-tapping with t25 stardrive recess, one (1) 5.0mm/30mm locking screw self-tapping with t25 stardrive recess, one (1) 5.0mm/32mm locking screw self-tapping with t25 stardrive recess, and one (1) 5.0mm/36mm locking screw self-tapping with t25 stardrive recess.The plate was broken on an unknown date.The devices were explanted.Patient's broken hardware was replaced with new hardware for stability.It is unknown if there was a surgical delay.Procedure outcome and patient status are unknown.Concomitant devices reported: 4.5 mm/ 32mm cortex screw self-tapping (214.832, lot#unknown, quantity 2), 4.5mm/36mm cortex screw self-tapping (214.836, lot#unknown, quantity 1), 5.0mm/28mm locking screw self-tapping with t25 stardrive recess (212.208, lot#unknown, quantity 1), 5.0mm/30mm locking screw self-tapping with t25 stardrive recess (212.209, lot# unknown, quantity 1), 5.0mm/32mm locking screw self-tapping with t25 stardrive recess (212.210, lot# unknown, quantity 1), 5.0mm/36mm locking screw self-tapping with t25 stardrive recess (212.212, lot# unknown, quantity 1).This report is for one (1) 4.5mm narrow lcp plate.This is report 1 of 1 for complaint (b)(4).

• Brand Name: 4.5MM NARROW LCP® PLATE 6 HOLES/116MM
• 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: 8578543
• Report Number: 2939274-2019-57826
• Device Sequence Number: 11221842
• Product Code: HRS
• UDI-Device Identifier: 10886982158468
• UDI-Public: (01)10886982158468
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K082807
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/06/2019

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: 224.561
• Device Catalogue Number: 224.561
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/06/2019
• Initial Report FDA Received Date: 05/03/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention