MAUDE Adverse Event Report: SYNTHES ELMIRA 2.7/3.5MM VA-LCP ANTEROLATERAL DISTAL TIBIA PL/8 HOLES/LEFT; PLATE,FIXATION,BONE

Catalog Number	02.118.207
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 used for treatment, not diagnosis.Additional narrative: event date: unknown.Additional product code: hwc.Original implant date is unknown.Device is not expected to be returned for manufacturer review/investigation, was discarded by facility.Device history records review was conducted.The report indicates that the: manufacturing location: product manufacture date: 03-jun-2014, product manufacture location: synthes (b)(4).A review of the device history record (dhr) revealed no complaint related anomalies.The (dhr) shows this lot of 2.7/3.5mm va-lcp anterolateral distal tibia plate/8 holes/left (part number 02.118.207, lot number 7694739) 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.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 received a plate and screws on an unknown date and fell off a ladder decorating for christmas in (b)(6) 2016.The patient experienced some pain and went back to see the doctor.An x-ray was performed on (b)(6) 2017 to check the incision site.X-ray showed a broken plate.The patient underwent a revision on (b)(6) 2017 to remove the broken plate.The broken plate was removed without issues.The screws that were removed were all intact.The patient was revised with a new plate and screws.There was no time delay reported.The procedure was completed successfully.Patient status was stable.No additional information is available.This complaint involves one (1) 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 ANTEROLATERAL DISTAL TIBIA PL/8 HOLES/LEFT
• Common Device Name: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• MDR Report Key: 6458791
• Report Number: 3003506883-2017-10050
• Device Sequence Number: 693647
• Product Code: HRS
• UDI-Device Identifier: 10886982038401
• UDI-Public: (01)10886982038401(10)7694739
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 03/16/2017

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: 02.118.207
• Device Lot Number: 7694739
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2017
• Initial Report FDA Received Date: 04/04/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Weight: 45