MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM LCP(TM) PLATE 10 HOLES/94MM; PLATE, FIXATION, BONE

Model Number	247.374
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Discomfort (2330); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient¿s height reported as 155.00 cms.Additional patient¿s identifier: (b)(6).Date of event: unknown.Complainant part is not expected to be returned for manufacturer review/investigation.A device history record (dhr) review was conducted for part: 247.374, lot: l204818: manufacturing site: mezzovico, release to warehouse date: 21.Nov.2016: the device history record shows this lot of 12 pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and material criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.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.
Event or Problem Description
It was reported that the patient underwent a removal surgery of the locking compression plate (lcp) plate 10 holes, one (1) locking screw and five (5) cortex screws on (b)(6) 2018, due to the plate being prominent on the bone and uncomfortable to the patient.No new implants were needed due to the clavicle fracture being healed.The removed implants were reported to be in good condition.Originally patient underwent a surgery on (b)(6) 2016, due to a clavicle fracture, and was revised on (b)(6) 2017 due to an overactive trapezius tendon that resulted in a bent plate (this event was captured on (b)(4) complaint (b)(4)).Revision surgery recently was completed successfully with no surgical delay.Patient is reported in stable condition.Concomitant devices reported: 5.0 locking screw self-tapping with t25 stardrive recess 32mm (part #: 212.210, lot #: unknown, quantity: 1), 2.7mm cortex screw self-tapping with t8 stardrive recess 12mm (part #: 202.872, lot #: unknown, quantity: 2), 2.7mm cortex screw self-tapping with t8 stardrive recess 16mm (part #: 202.876, lot #: unknown, quantity: 1), 2.7mm cortex screw self-tapping with t8 stardrive recess 16mm (part #: 202.876, lot #: unknown, quantity: 1), 2.7mm cortex screw self-tapping with t8 stardrive recess 18mm (part #: 202.878, lot #: unknown, quantity: 1), and 2.7mm cortex screw self-tapping with t8 stardrive recess 20mm (part #: 202.880, lot #: unknown, quantity: 1).This report is for one (1) 2.7mm lcp(tm) plate 10 holes/94mm.This is report 1 of 1 for (b)(4).

• Brand Name: 2.7MM LCP(TM) PLATE 10 HOLES/94MM
• 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: 7866893
• Report Number: 2939274-2018-53747
• Device Sequence Number: 1703439
• Product Code: HRS
• UDI-Device Identifier: 10886982170880
• UDI-Public: (01)10886982170880
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K063049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/22/2018

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: 247.374
• Device Catalogue Number: 247.374
• Device Lot Number: L204818
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/22/2018
• Initial Report FDA Received Date: 09/11/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR