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

Model Number	226.591
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Additional device product codes: hwc, ktt.Implanted in (b)(6) 2013, exact date is unknown.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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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) 2018 for removal of 4.5mm broad locking compression plate (lcp) 9 holes/170mm and unknown screws implanted on (b)(6) 2013.The revision surgery was carried out as the patient had the complaint of sensitivity to the plate on the humerus.During the revision surgery one 4.5mm broad lcp plate 9 holes/170mm and ten unknown screws were removed intact.Nothing was implanted after removal of plate and screws.Successful union of fracture had occurred.The procedure was successfully completed without any surgical delay.The patient was stable after the surgery.This report is for one (1) 4.5mm broad lcp® plate 9 holes/170mm.(b)(4).

• Brand Name: 4.5MM BROAD 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: 7361521
• Report Number: 2939274-2018-51157
• Device Sequence Number: 128357
• Product Code: HRS
• UDI-Device Identifier: 10886982159090
• UDI-Public: (01)10886982159090(10)LOTNUMBERUNKNOWN
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/22/2018

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: 226.591
• Device Catalogue Number: 226.591
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/22/2018
• Initial Report FDA Received Date: 03/22/2018
• 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: 30 YR
• Patient Weight: 102