MAUDE Adverse Event Report: SYNTHES ELMIRA 4.5MM NARROW LCP® PLATE 7 HOLES/134MM; PLATE, FIXATION, BONE

Model Number	224.571
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Date of non-union is not known.Additional product codes: hwc, ktt.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 dhr review was completed.Product manufacture date: 09-jan-2017.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 4.5 mm narrow lcp plate 7 holes/134 mm (part number 224.571, lot number h266040) 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.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 revision of a plate and six screws on (b)(6) 2017 due to nonunion.The plate and screws were originally implanted on (b)(6) 2017 for a right midshaft tibial fracture.At the time of the original surgery, the patient had refused treatment with a nail.A nonunion was discovered on an unknown date postoperatively.The plate and screws were removed intact and patient was revised to a nail and locking screws with bone graft.The surgery was successfully completed with no delay.The patient outcome was reported as fine.This report is for one (1) 4.5 mm narrow lcp plate.This is report 1 of 7 for (b)(4).

• Brand Name: 4.5MM NARROW LCP® PLATE 7 HOLES/134MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• MDR Report Key: 6839493
• Report Number: 3003506883-2017-10194
• Device Sequence Number: 58793
• Product Code: HRS
• UDI-Device Identifier: 10886982158482
• UDI-Public: (01)10886982158482(10)H266040
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K082807
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/11/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: 224.571
• Device Catalogue Number: 224.571
• Device Lot Number: H266040
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2017
• Initial Report FDA Received Date: 09/01/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 81