MAUDE Adverse Event Report: SYNTHES ELMIRA 4.5MM NARROW LC-DCP® PLATE 7 HOLES/124MM; PLATE, FIXATION, BONE

Catalog Number	224.57
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Impaired Healing (2378)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient exact weight reported as (b)(4).(therapy date): unknown.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested.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 a patient underwent a hardware removal on (b)(6) 2016, due to nonunion of the right humerus.The surgeon removed a 4.5mm limited contact dynamic compression plate (lc-dcp) and six (6) 4.5mm cortex screws.One of the 4.5 cortex screw heads broke off upon removal.The surgeon used a screw removal set to retrieve the remaining screw fragment.He also removed a 2.7 cortex screw, a 4-hole 2.4mm plate and two (2) 2.4mm screws.The surgeon revised the fracture with a 5-hole 4.5 narrow locking compression plate (lcp) with screws and gained compression of the fracture using the articulated tension device.He also added an 8-hole 3.5 lcp plate and screw.The procedure was successfully completed with no surgical delay reported.The patient outcome/status is well.This report address the nonunion requiring a revision procedure.The intra-operative broken screw is being captured under linked complaint com-(b)(4).Concomitant device reported: screw removal set (part unknown, lot unknown, quantity unknown); 2.7 cortex screw (part unknown, lot unknown, quantity 1); 2.4 mm screws (part unknown, lot unknown, quantity 2); 4.5 narrow lcp plate (part unknown, lot unknown, quantity 1); 8-hole 3.5 clp plate (part unknown, lot unknown, quantity 1); screws (part unknown, lot unknown, quantity unknown).This is report 1 of 2 for com-(b)(4).
Additional Manufacturer Narrative
Additional narrative: describe event or problem.Part 224.57, lot 5467453: part manufacture date: march 24, 2007.A review of the device history record revealed no complaint related anomalies.The device history record shows this lot of 4.5 mm narrow lc-dcp plates was processed through the normal manufacturing and inspection operations with no non-conformance noted.This 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.The review of the raw material device history record revealed this lot met all specifications with no non-conformance 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: previously reported concomitant devices were reported error.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 two plates and nine screws were removed due to the non-union.This is report 1 of 5 for (b)(4).

• Brand Name: 4.5MM NARROW LC-DCP® PLATE 7 HOLES/124MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• MDR Report Key: 6279611
• Report Number: 3003506883-2017-10011
• Device Sequence Number: 612817
• Product Code: HRS
• UDI-Device Identifier: 10886982158475
• UDI-Public: (01)10886982158475(10)5467453
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMEND
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2016

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 Catalogue Number: 224.57
• Device Lot Number: 5467453
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/28/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/26/2017
• Supplement Report FDA Received Date: 02/08/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ONE UNKNOWN 2.7 CORTEX SCREW; ONE UNKNOWN 4.5 NARROW LCP PLATE; ONE UNKNOWN 8-HOLE 3.5 CLP PLATE; TWO UNKNOWN 2.4 MM SCREWS; UNKNOWN QUANTITY OF DEVICES FROM SCREW REMOVAL SET; UNKNOWN QUANTITY OF UNKNOWN SCREWS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 25 YR
• Patient Weight: 52