MAUDE Adverse Event Report: SYNTHES ELMIRA 2.7/3.5MM VA-LCP ANTEROLATERALDISTAL TIBIA PLATE/8 HOLES/RIGHT; PLATE, FIXATION, BONE

Catalog Number	02.118.206
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Impaired Healing (2378); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Additional device product code is hwc.The subject device is not expected to be returned to the synthes manufacturer for evaluation.The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history record (dhr) review was performed for the subject device lot.Manufacturer: (b)(4).Date of manufacture: oct 7, 2015.The review of the dhr revealed no complaint related anomalies.The dhr shows this lot of 2.7/3.5mm va-lcp anterolateral distal tibia plate/8 holes/right (part number 02.118.206, lot number 9913823) was processed through the normal manufacturing and inspection operations with no non-conformances or rework noted.This order met all dimensional and visual 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 non-conformances or rework noted.(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 a revision surgery was performed due to a nonunion and plate breakage.The initial open reduction internal fixation (orif) of the right pilon fracture procedure was performed on (b)(6) 2016.Patient was initially implanted with one (1) 2.7mm/3.5mm variable angle (va) locking compression plate (lcp), unknown quantity of 3.5mm cortical screws, and an unknown quantity of 2.7mm va locking screws.During a follow up visit on an unknown date, it was discovered by x-ray that the plate had broken and patient had nonunion.The x-rays did not show any screw breakage.It is unknown how the breakage and nonunion were discovered and if patient reported any adverse events.Patient had revision surgery on (b)(6) 2017.During revision surgery, it was discovered that the heads of four (4) 2.7mm va locking screws had broken during removal.It is unknown if the screws broke prior or during revision surgery.No fragments were generated due to broken devices.The implants were easily removed without requiring medical intervention.The cortical screws and remaining va locking screws were removed intact.Patient was revised to one (1) 3.5mm lcp antero-lateral plate and unknown quantity of screws.Surgeon also added one (1) 3.5mm reconstruction plate to the fibia and unknown quantity of screws for stabilization.The revision surgery was successfully completed without surgical delay.The patient outcome was reported as stable.This report addresses the postoperative breakage of the plate, nonunion, and the resulting revisions surgery.The incident of the intraoperative 2.7mm screw breakage is addressed in related complaint (b)(4).Concomitant medical products: 2.7mm va locking screws (part # unknown, lot # unknown, quantity of 4) and 3.5mm cortical screws (part # unknown, lot # unknown, quantity unknown).This report is 1 of 1 for (b)(4).

• Brand Name: 2.7/3.5MM VA-LCP ANTEROLATERALDISTAL TIBIA PLATE/8 HOLES/RIGHT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• MDR Report Key: 6294243
• Report Number: 3003506883-2017-10013
• Device Sequence Number: 16155319
• Product Code: HRS
• UDI-Device Identifier: 10886982038388
• UDI-Public: (01)10886982038388(10)9913823
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K121601
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/11/2017

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: 02.118.206
• Device Lot Number: 9913823
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2017
• Initial Report FDA Received Date: 02/01/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN 2.7MM VA LOCKING SCREWS, QTY 4; UNKNOWN 3.5MM CORTICAL SCREWS, QTY UNKNOWN.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 78