MAUDE Adverse Event Report: SYNTHES ELMIRA 4.5MM LCP® CURVED CONDYLAR PLATE 14 HOLES/314MM-LEFT; APPLIANCE, FIXATION, NAIL

Catalog Number	02.001.304
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.The subject device is not expected to be returned to the synthes manufacturer for evaluation and was reportedly discarded by the hospital.The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history record review was performed for the subject device lot.Manufacturer: (b)(4).Date of manufacture date: feb 27, 2015.The review of the device history record revealed no complaint related anomalies.The device history record shows this lot of 4.5mm curved condylar 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.(b)(4).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 revision surgery with hardware removal was performed on (b)(6) 2017 due to a broken distal femoral plate and patient pain.The patient initially underwent an unknown procedure and was implanted with the plate and screws on an unknown date.Upon clinical follow-up on an unknown date, the patient presented with complaints of pain.An unknown diagnostic procedure was performed on an unknown date that revealed the broken plate.The patient underwent a distal femur plate and screw revision on (b)(6) 2017.The surgeon removed the broken plate without complications.There were several unknown screws that were also removed, however, two (2) of the screws broke at the head, making it difficult to remove the remainder of the screw shaft.The two (2) broken screw shafts were left inside the patient.The patient was revised with one (1) new plate and screws.The procedure was completed with no other complications or surgical time delay.The patient¿s postoperative status was stable.This complaint is related to complaint, (b)(4), which addresses and reports the two (2) broken unknown screws and retained fragments.This report addresses the event of patient pain and the broken plate.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
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
Concomitant medical products: screws (part # unknown, lot # unknown, quantity unknown).

• Brand Name: 4.5MM LCP® CURVED CONDYLAR PLATE 14 HOLES/314MM-LEFT
• Common Device Name: APPLIANCE, FIXATION, NAIL
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• MDR Report Key: 6367931
• Report Number: 3003506883-2017-10027
• Device Sequence Number: 634736
• Product Code: KTT
• UDI-Device Identifier: 10886982027573
• UDI-Public: (01)10886982027573(10)7932015
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K041911
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2017

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 02.001.304
• Device Lot Number: 7932015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/02/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/01/2017
• Supplement Report FDA Received Date: 03/31/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 111