MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LCP HOOK PLATE 3 HOLE STERILE; PLATE, FIXATION, BONE

Model Number	02.113.103S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	08/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported height of the patient is: 175.26 cms.Date of actual ankle fracture is unknown, sometime in (b)(6) 2018.Complainant device is not expected to be returned for manufacturer review/investigation.Without a lot number, the device history records review, and 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 underwent an open reduction internal fixation on (b)(6) 2018 due to fall and had a distal medial tibial fracture which is just above the locking compression plate that had been implanted on (b)(6) 2018 to fix a broken ankle.In addition, one (1) locking compression plate (lcp) hook plate and (2) unknown cortex screws and (2) unknown locking screws were removed from a previous ankle surgery on the month of (b)(6) 2018 in order to fit the new plate and screws.The ankle fracture was noted as healing without a non-union.All the hardware was intact.The surgery was completed successfully.No additional medical intervention was necessary.The patient was stable following surgery.This is report 1 of 3 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Event date: year of event reported as 2018; however exact date of postoperative fracture is unknown.The incorrect date was inadvertently utilized in initial medwatch.The correct date is (b)(6) 2018.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.

• Brand Name: 3.5MM LCP HOOK PLATE 3 HOLE STERILE
• 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: 7864240
• Report Number: 2939274-2018-53713
• Device Sequence Number: 11182158
• Product Code: HRS
• UDI-Device Identifier: 10886982034731
• UDI-Public: (01)10886982034731
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K082072
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2018

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: 02.113.103S
• Device Catalogue Number: 02.113.103S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/21/2018
• Supplement Date Received by Manufacturer: 10/08/2018
• Initial Report FDA Received Date: 09/11/2018
• Supplement Report FDA Received Date: 10/11/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Weight: 154