MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LCP RECONSTRUCTION PLATE 7 HOLES/98MM; APPLIANCE, FIXATION, NAIL

Model Number	245.071
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Swelling (2091); Reaction (2414)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient id/initials and weight are unknown.Patient age reported as in her 70¿s.Swelling began on an unknown date in 2018.Unknown date approximately thirteen (13) years ago.Device has not been reported as explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is a johnson and johnson employee.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 is looking to see what metal was in the plates that she had implanted approximately thirteen (13) years ago.She stated she recently had swelling in her arms and was unsure if this was related to her age or the implants.This is report 2 of 3 for (b)(4).

• Brand Name: 3.5MM LCP RECONSTRUCTION PLATE 7 HOLES/98MM
• Common Device Name: APPLIANCE, FIXATION, NAIL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7814297
• Report Number: 2939274-2018-53467
• Device Sequence Number: 2386937
• Product Code: KTT
• UDI-Device Identifier: 10886982169600
• UDI-Public: (01)10886982169600
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K000684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/06/2018

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: 245.071
• Device Catalogue Number: 245.071
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2018
• Initial Report FDA Received Date: 08/24/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR