MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LCP EXTRA-ARTICLR DISTAL HUMERUS PL 10H/LT 230MM LONG; PLATE, FIXATION, BONE

Model Number	02.104.030
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pocket Erosion (2013)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient weight is unknown.Date of event: unknown.Complainant part is not expected to be returned for manufacturer review/investigation.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 the patient underwent implantation of two (2) locking compression plate (lcp) distal humeral plates and unknown screws on (b)(6) 2018.On an unknown date, patient developed hardware issues.On (b)(6) 2018, patient underwent hardware removal due to the plates breaking through the skin.There was no surgical delay reported.Procedure was completed successfully and patient status was stable.This is report 1 of 3 for (b)(4).

• Brand Name: 3.5MM LCP EXTRA-ARTICLR DISTAL HUMERUS PL 10H/LT 230MM 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: 7681391
• Report Number: 2939274-2018-52844
• Device Sequence Number: 13805302
• Product Code: HRS
• UDI-Device Identifier: 10886982029164
• UDI-Public: (01)10886982029164
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K031178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/14/2018

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: 02.104.030
• Device Catalogue Number: 02.104.030
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/14/2018
• Initial Report FDA Received Date: 07/12/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR