MAUDE Adverse Event Report: WRIGHTS LANE: SYNTHES USA PRODUCTS LLC 3.5MM LCP PLATE 10 HOLES 137MM; PLATE, FIXATION, BONE

Model Number	223.601
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient id/initials, age/date of birth and weight are unknown.Date of event: unknown.Additional product codes: hwc, ktt.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is consumer complaint coordinator with fda.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 an orthopaedic fixation procedure on her right leg and ankle on (b)(6) 2013.The patient reported that the bone healed however, she was in chronic pain and had experienced limited range of motion, and as a result, she had two (2) of the eight (8) pins (screws) removed from her ankle on (b)(6) 2013.No reported surgical delay or patient harm.In (b)(6) 2014, the patient resumed physical therapy, and felt better for about two-three months, however she began having the pain again, in a different place.She stated that she would experience sharp shooting pain going up the back of her leg.In 2016, patient stated that she began receiving treatment.On (b)(6) 2017, the patient had surgery to have the hardware from her ankle removed.No reported surgical delay or patient harm.This report addresses the second removal procedure on (b)(6) 2017.Related complaint (b)(4) addresses the first procedure on (b)(6) 2013.This is report 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 further reported that all remaining hardware were removed and patient was not revised to any other hardware on (b)(6) 2017.Reportedly, the procedure was completed successfully.

• Brand Name: 3.5MM LCP PLATE 10 HOLES 137MM
• 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: 7216763
• Report Number: 2939274-2018-50390
• Device Sequence Number: 11040345
• Product Code: HRS
• UDI-Device Identifier: 10886982157997
• UDI-Public: (01)10886982157997(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K082807
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2018

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: 223.601
• Device Catalogue Number: 223.601
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/16/2018
• Supplement Date Received by Manufacturer: 01/29/2018
• Initial Report FDA Received Date: 01/24/2018
• Supplement Report FDA Received Date: 02/28/2018
• 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 Weight: 107