MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM CURVED BROAD LCP® PLATE 13 HOLES/247MM; SCREW, FIXATION, BONE

Model Number	212.211
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product codes: ktt, hrs.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.Without a lot number the device history records review could not be completed.Product was not returned.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.
Event or Problem Description
It was reported that on (b)(6) 2018, the patient underwent a plate removal because of the broken 4.5mm curved broad locking compression plate.This surgery was to repair the non-union of a fracture.It is also unknown if there were a surgical delay.Procedure and the patient's outcome is unknown.This complaint involves one (1) device.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Device history lot part: 226.632, lot: 2123079, manufacturing site: (b)(4), release to warehouse date: 14.Mar.2005.The device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual 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.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.
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.H10: additional narrative: a1: patient id: (b)(4), b5, d4: lot number, d11.B4/g4: initial awareness date should be october 31, 2018 not november 01, 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.
Event or Problem Description
It was reported that on october 31, 2018, the patient underwent a plate removal because of the broken 4.5mm curved broad locking compression plate.There was a surgery to repair the non-union of the fracture.Patient required additional intervention because the original fracture had not yet healed when the broken plate was removed, doctor implanted an antegrade femoral nail.Surgical delay is unknown.Procedure outcome was successful.Patient status is unknown.Concomitant device reported: locking screws (part/lot unknown, quantity 11).

• Brand Name: 4.5MM CURVED BROAD LCP® PLATE 13 HOLES/247MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8085718
• Report Number: 2939274-2018-55021
• Device Sequence Number: 295114
• Product Code: HWC
• UDI-Device Identifier: 10886982152183
• UDI-Public: (01)10886982152183
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K082807
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/01/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 212.211
• Device Catalogue Number: 226.632
• Device Lot Number: 2123079
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/01/2018
• Supplement Date Received by Manufacturer: 12/06/2018; 12/26/2018
• Initial Report FDA Received Date: 11/19/2018
• Supplement Report FDA Received Date: 12/21/2018; 12/27/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention