MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LCP SUPERIOR CLAVICLE PLATE W/LAT EXTN/6H/LT/105MM; PLATE,FIXATION,BONE

Model Number	02.112.091
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Product was not returned.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 an unknown date, the patient underwent an unknown procedure.While the surgeon was operating on a right clavicle, it was found out near the end of the case that a locking compression plate (lcp) clavicle plate with lateral extension was a left.It was also reported that the surgeon was informed immediately by the sales consultant.It was mentioned that there was no issue on the packaging of labeling.It was improper implant selection.The procedure was successfully completed with no surgical delay.The patient outcome is unknown.This is report 1 for 1 (b)(4).

• Brand Name: 3.5MM LCP SUPERIOR CLAVICLE PLATE W/LAT EXTN/6H/LT/105MM
• 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: 9156558
• Report Number: 2939274-2019-61197
• Device Sequence Number: 19440527
• Product Code: HRS
• UDI-Device Identifier: 10886982033239
• UDI-Public: (01)10886982033239
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K111540
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 02.112.091
• Device Catalogue Number: 02.112.091
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/11/2019
• Initial Report FDA Received Date: 10/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR