MAUDE Adverse Event Report: SYNTHES ELMIRA 2.7/3.5MM VA-LCP ANTEROLATERALDISTAL TIBIA PL/6 HOLES/LEFT; PLATE, FIXATION, BONE

Model Number	02.118.205
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.Date of event: unknown.Implanted date: original implant date is unknown.Device is not expected to be returned for manufacturer review/investigation.Device history records review was conducted.The report indicates that the: part mfg date: 25 october 2016, part exp.Date: n/a (for sterile part numbers only), manufacturing location: (b)(6).Dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of 2.7/3.5mm va-lcp anterolateral distal tibia pl/6 holes/ left was processed through the normal manufacturing and inspection operations with no nonconformance 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 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.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 patient had a revision surgery on (b)(6) 2017 for a non-union and a broken 2.7mm / 3.5mm variable angle 6 hole left plate of a distal tibia.Surgeon removed the plate and associated screws.Patient was implanted with a new 3.5mm cannulated angled blade plate.There was no delay in surgery, patient's outcome was as planned.Surgery was successfully completed.This complaint involves one device.Concomitant devices reported: 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 PL/6 HOLES/LEFT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• MDR Report Key: 7037488
• Report Number: 3003506883-2017-10267
• Device Sequence Number: 11004414
• Product Code: HRS
• UDI-Device Identifier: 10886982038364
• UDI-Public: (01)10886982038364(10)H216428
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K121601
• 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
• Report Date (Section B): 10/24/2017

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 Model Number: 02.118.205
• Device Catalogue Number: 02.118.205
• Device Lot Number: H216428
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2017
• Initial Report FDA Received Date: 11/16/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 36 YR