MAUDE Adverse Event Report: SYNTHES ELMIRA 4.5MM NARROW LCP® PLATE 12 HOLES/224MM; PLATE, FIXATION, BONE

Model Number	224.621
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
Patient¿s height reported as 5 feet 10 inches.(b)(6).Date of postoperative plate breakage is unknown.Additional device product codes: hwc, ktt.Initial implant date is unknown, approximately three years prior to hardware removal surgery.Complainant device is not expected to be returned for manufacturer review/investigation.Therapy date is approximately three years prior to hardware removal surgery.A device history record (dhr) review was performed for part # 224.621 and lot # 4741504: product manufactured in (b)(4), product manufacture date: 12-apr-2004: a review of the device history record (dhr) revealed no complaint related anomalies.The dhr shows this lot of 4.5mm narrow lcp plate 12 holes/224mm (part number 224.621, lot number 4741504) 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 performed and there were no issues during the manufacture of the product that would contribute to this complaint condition.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 hardware removal and revision was performed on (b)(6) 2017 due to a broken plate and non-union.The original procedure was performed on an unknown date, three years prior.Patient is labor worker and started working before bone healed.The plate had broken down the middle, over a non-union of the right humerus.Removed hardware included the plate (broken), three cables (intact) and ten screws (intact).The patient was revised to a metaphyseal plate and screws and 3 cables with bone grafting.There were no reported surgical delays, no fragments involved and no additional x-rays required.The procedure was completed successfully with the patient in stable condition.Concomitant devices reported: 1.7mm cable with crimp 750mm (part # 298.801.01, lot # unknown, quantity # 3), 5.0mm locking screw slf-tpng with t25 stardrive recess 28mm (part # 212.208, lot # unknown, quantity # 3), 5.0mm locking screw slf-tpng with t25 stardrive recess 30mm (part # 212.209, lot # unknown, quantity # 4), 5.0mm locking screw slf-tpng with t25 stardrive recess 32mm (part # 212.210, lot # unknown, quantity # 3).This report is for one (1) 4.5mm narrow lcp® plate.This is report 1 of 1 for complaint (b)(4).

• Brand Name: 4.5MM NARROW LCP® PLATE 12 HOLES/224MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• MDR Report Key: 6722299
• Report Number: 3003506883-2017-10134
• Device Sequence Number: 18887059
• Product Code: HRS
• UDI-Device Identifier: 10886982158581
• UDI-Public: (01)10886982158581(10)4741504
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K082807
• 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): 06/21/2017

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: 224.621
• Device Catalogue Number: 224.621
• Device Lot Number: 4741504
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2017
• Initial Report FDA Received Date: 07/18/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 99