MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 8 HOLES/93MM; PLATE, FIXATION, BONE

Model Number	241.381
Medical Device Problem Codes	Defective Device (2588); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 (b)(6) 2019, a patient underwent an open reduction and internal fixation (orif) of the ankle.A threaded drill guide cross threaded possibly due to a burr on the thread and caused a burr on the locking compression plate/tubular plate which poked the surgeon's finger.Nothing seemed to come off of the instrument or plate.There was no surgical delay.Procedure was successfully completed.Patient outcome was unknown.This report is for a locking compression plate/tubular plate.This is report 1 of 2 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.H3, h4, h6: part 241.381, lot h241230: part manufacture date: november 29, 2016.Manufacturing location: elmira.A review of the device history record (dhr) revealed no complaint related anomalies.The device history record shows this lot of lcp one-third tubular plate with collar 8 holes/93mm product 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.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.H3, h6: a product investigation was completed: the returned device was examined and minor wear/surface abrasions consistent with implantation and explantation were noted.One end of the plate was possibly bent with pliers which deformed end hole and threads.The received condition would impact the device functionality.Overall complaint was confirmed.Due to bent tubular plate, complaint condition regarding device interaction was unable to be replicated.The dimensional analysis was within specification.Dimensional analysis was not performed on bent side of plate since there was no visual damage discovered except for the bent tip and thread.The relevant drawings were reviewed during investigation.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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: LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 8 HOLES/93MM
• 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: 8371534
• Report Number: 2939274-2019-56686
• Device Sequence Number: 1058201
• Product Code: HRS
• UDI-Device Identifier: 10886982166913
• UDI-Public: (01)10886982166913
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K011335
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2019

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: 241.381
• Device Catalogue Number: 241.381
• Device Lot Number: H241230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2019
• Initial Date Received by Manufacturer: 02/01/2019
• Supplement Date Received by Manufacturer: 03/21/2019
• Initial Report FDA Received Date: 02/26/2019
• Supplement Report FDA Received Date: 03/25/2019
• Patient Sequence Number: 1