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

Model Number	223.56
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional narrative: device was used for treatment, not diagnosis.Patient age not available for reporting.Unknown date of event; it is unknown when the pain began.Original surgery done in 2008, subsequent revision in 2014.Complainant part is not expected to return for investigation.Device history record review is pending.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 a right elbow hardware removal was performed on (b)(6) 2018 due to patient complaints of pain.The original procedure was performed on an unknown date in 2006, and was revised in 2014.Removed hardware included two intact plates and a total of twelve intact cortical screws (a combination of 3.5mm and 2.7mm).One 3.5mm cortical screw head broke off during the removal.The broken screw head and the embedded shaft was retrieved.There was a surgical delay of five minutes to retrieve the screw shaft.No additional x-rays or other medical intervention required.No signs of infection.The area was fully healed.The procedure was completed successfully with the patient in stable condition.The complaint of screw broken intra-op is captured in (b)(4).(b)(4).
Additional Manufacturer Narrative
Patient¿s height reported as 6 feet.A device history record (dhr) review was performed for part number: 223.56, lot number: 5061305: part manufacture date: 01-sep-2005, manufacturing location: (b)(4), part expiration date: n/a, nonconformance noted: n/a: 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 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.Corrected data: original procedure performed on an unknown date in 2006, subsequent revision in 2014.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 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: 7212061
• Report Number: 2939274-2018-50369
• Device Sequence Number: 763924
• Product Code: HRS
• UDI-Device Identifier: 10886982157904
• UDI-Public: (01)10886982157904(10)5061305
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMEND
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2018

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: 223.56
• Device Catalogue Number: 223.56
• Device Lot Number: 5061305
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/02/2018
• Supplement Date Received by Manufacturer: 02/28/2018
• Initial Report FDA Received Date: 01/23/2018
• Supplement Report FDA Received Date: 03/01/2018
• 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 Weight: 93