MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LCP LOW BEND MEDIAL DSTL TIBIA PLATE/6H/RT/135MM-STER; PLATE, FIXATION, BONE

Model Number	02.112.514S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient id: (b)(6).Complainant part is not expected to be returned for manufacturer review/investigation.Phone number extension: (b)(6).Part: 02.112.514s, lot: h123196: part manufacture date: july 13, 2016.Manufacturing location: (b)(4).A review of the device history record revealed no complaint related anomalies.The device history record shows this lot of devices was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.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, the locking compression plate, locking screw 36mm, locking screw 30mm and variable angle locking compression plate (va-lcp) were implanted due to right ankle fracture.The surgeon asked for a metal allergy test of what particular plate is made of.The patient had an adverse reaction to the plate.It is unknown if there was surgical delay.Procedure outcome is unknown.This report is for a lcp low bend medial dstl tibia plate.This is report 1 of 4 for (b)(4).
Event or Problem Description
Update: allergy testing will not be completed until early (b)(6) 2019.It is a 4 ¿ 6 step process.
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.Expiration date provided for reporting.Additional information provided for reporting.Product was not returned.Based on the information available, it has been determined that no corrective and 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.

• Brand Name: 3.5MM LCP LOW BEND MEDIAL DSTL TIBIA PLATE/6H/RT/135MM-STER
• 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: 8383732
• Report Number: 2939274-2019-56757
• Device Sequence Number: 312434
• Product Code: HRS
• UDI-Device Identifier: 10886982034526
• UDI-Public: (01)10886982034526
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K013248
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2019

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 Expiration Date: 06/30/2021
• Device Model Number: 02.112.514S
• Device Catalogue Number: 02.112.514S
• Device Lot Number: H123196
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/07/2019
• Supplement Date Received by Manufacturer: 04/03/2019
• Initial Report FDA Received Date: 03/01/2019
• Supplement Report FDA Received Date: 04/03/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR
• Patient Weight: 91