MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM NARROW LCP® PLATE 9 HOLES/170MM; PLATE, FIXATION, BONE

Model Number	224.591
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Age, dob and weight not provided for reporting.Date of event: unknown.Additional product code: ktt.Original surgery was (b)(6) 2014.Revision on (b)(6) 2017.Complainant device is not expected to be returned for manufacturer review/investigation.(b)(4).The investigation could not be completed; no conclusion could be drawn, as no product was received.Investigation summary: 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 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 a patient had to undergo a revision surgery on (b)(6) 2015 for nonunion of humerus.The original surgery was done on (b)(6) 2014.During the revision surgery, one plate, seven 4.5 mm cortex screws and one 5.0 mm locking screw were removed intact.The patient was implanted with one 4.5 mm narrow lcp® plate 8 holes/152 mm, three 4.5 mm cortex screws, three 4.0 mm cortex screws, one 3.5 mm lcp plate 6 holes 85 mm holes/152 mm, three 3.5 mm cortex screws and two 3.5 mm locking screws.The intra-op cultures came back positive from the day of surgery.No other details are available.This complaint involves three (3) devices.This report is 1 of 3 for (b)(4).
Additional Manufacturer Narrative
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 had to undergo a revision surgery on (b)(6) 2015 for nonunion of humerus.The original surgery was done on (b)(6) 2014.During the revision surgery, one (1) plate, seven (7) 4.5mm cortex screws and one (1) 5.0mm locking screw were removed intact.The patient was revised to one (1) 4.5mm narrow locking compression plate (lcp) plate 8 holes/152mm, three (3) 4.5mm cortex screws, three (3) 4.0mm cortex screws, one (1) 3.5mm lcp plate 6 holes 85mmholes/152mm, three (3) 3.5mm cortex screws and two (2) 3.5mm locking screws.This is report 1 of 3 for (b)(4).

• Brand Name: 4.5MM NARROW LCP® PLATE 9 HOLES/170MM
• 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: 7216678
• Report Number: 2939274-2018-50388
• Device Sequence Number: 13493791
• Product Code: HRS
• UDI-Device Identifier: 10886982158529
• UDI-Public: (01)10886982158529(10)LOTUNKNOWN
• Combination Product (Y/N): N
• PMA/510(K) Number: K082807
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: 224.591
• Device Catalogue Number: 224.591
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/04/2018
• Supplement Date Received by Manufacturer: 02/15/2018
• Initial Report FDA Received Date: 01/24/2018
• Supplement Report FDA Received Date: 02/15/2018
• 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