MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LCP PLATE 8 HOLES 111MM; PLATE, FIXATION, BONE

Model Number	223.581
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Narrative: device was used for treatment, not diagnosis.Patient weight not available for reporting.Unknown when condition began.Device is not expected to return for investigation.(b)(4).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.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 patient underwent original surgery for treatment of a proximal tibial fracture on (b)(6) 2016.Post-operatively, patient complained that when the weather changes,her feet would feel very cold about the implant site.On (b)(6) 2018, patient underwent hardware removal surgery and the following devices fourteen (14) were removed - one (1) proximal tibia plate, one (1) locking compression tubular plate, one (1) 8 holes locking compression plate, two (2) 4.5 mm cortex screws, four (4) 5.0 mm locking screws and five (5) 3.5 mm cortex screws.There was no reported malfunctions associated with any of the devices.All of the devices were removed easily and the patient is reported to be in stable condition.The hardware removal surgery was completed without any reported delay.(b)(4).
Additional Manufacturer Narrative
A device history record review was performed for the subject device: part number: 223.581, lot number: 7852541 , part mfg date: 17-nov-2014 , part exp.Date: n/a , manufacturing location: (b)(4).Dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of 3.5mm lcp plates 8 holes was processed through the normal manufacturing and inspection operations with no non-conformance noted.This lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.The review of the raw material device history record revealed this lot met all specifications with one nonconformance noted.A nonconformance (ncr) is associated with raw material lot 7349620.The ncr was initiated due to the raw material not meeting the packaging requirements due to the raw material being packaged in cardboard containers.Raw material lot 7349620 was dispositioned as rework as the raw material will be transferred to wooden crates upon receipt.Therefore, ncr is not relevant to this complaint.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition raw material lot 7349620 was dispositioned as rework as the raw material will be transferred to wooden crates upon receipt.Therefore, ncr is not relevant to this complaint.This raw material lot met all dimensional and visual criteria.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 PLATE 8 HOLES 111MM
• 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: 7313946
• Report Number: 2939274-2018-50872
• Device Sequence Number: 11337972
• Product Code: HRS
• UDI-Device Identifier: 10886982157959
• UDI-Public: (01)10886982157959(10)7852541
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K082807
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2018

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: 223.581
• Device Catalogue Number: 223.581
• Device Lot Number: 7852541
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/05/2018
• Supplement Date Received by Manufacturer: 03/14/2018
• Initial Report FDA Received Date: 03/05/2018
• Supplement Report FDA Received Date: 04/04/2018
• 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 Age: 50 YR