MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM TI LC-DCP® PLATE 6 HOLES/77MM; PLATE, FIXATION, BONE

Model Number	423.56
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
Patient information unknown.Event date unknown as we don¿t know when the patient began experiencing physical limitations when lifting.Implanted date: implant date is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.A review of the device history records has been requested.On (b)(6) 2017 two (2) plates and twelve (12) cortex screws were removed due to the patient having physical limitations when lifting.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 hardware was implanted on an unknown date in 2003 for a radius and ulna fracture.On (b)(6) 2017 two (2) plates and twelve (12) cortex screws were removed due to the patient having physical limitations when lifting.Two (2) 3.5mm ti lc-dcp plate 6 holes/77mm and seven (7) cortex screws were removed.Five (5) cortex screw shafts were retained in the ulna bone.This is report 1 of 3 for (b)(4).
Additional Manufacturer Narrative
Part number: 423.56, lot number: 4408401: part manufacture date: may 13, 2002.Manufacturing location: (b)(4).A review of the device history record revealed no complaint related anomalies.The device history record shows this lot of 3.5mm ti lc-dcp plate 6 holes/77mm 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.A review of the raw material device history record revealed this lot met all specifications with no nonconformance noted.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.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 is unknown if fragments were generated from the broken product.

• Brand Name: 3.5MM TI LC-DCP® PLATE 6 HOLES/77MM
• 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: 7033702
• Report Number: 2939274-2017-50006
• Device Sequence Number: 16315053
• Product Code: HRS
• UDI-Device Identifier: 10886982216274
• UDI-Public: (01)10886982216274(10)4408401
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: PRE-AMEND
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2017

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: 423.56
• Device Catalogue Number: 423.56
• Device Lot Number: 4408401
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/18/2017
• Supplement Date Received by Manufacturer: 12/12/2017
• Initial Report FDA Received Date: 11/15/2017
• Supplement Report FDA Received Date: 12/14/2017
• 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