MAUDE Adverse Event Report: SYNTHES RARON 3.5MM LCP RECONSTRUCTION PLATE 8 HOLES/112MM; APPLIANCE,FIXATION,NAIL

Catalog Number	245.081
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Device is not expected to be returned for manufacturer review/investigation.(b)(6).(b)(4).A device history record review was performed on part # 245.081 and lot # 7979081: manufacturing location: (b)(4), manufacturing date: 17.Jul.2012.No non conformance reports (ncrs) were generated during production.Review of the device history record(s) showed that 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 to repair both bone forearm fracture, open reduction internal fixation was performed on (b)(6) 2016 and the surgery was completed satisfactory.Upon follow up x-ray, it was determined that reconstruction plate broke and non union was present.Revision surgery was performed on (b)(6) 2017 to remove all the hardware and new plate and screws were implanted.Procedure was completed successfully.Explanted screws were intact.Concomitant medical products: 2.7 cortex screw (part # unknown, lot # unknown, quantity # 1), 3.5 cortex screws (part # unknown, lot # unknown, quantity # 7).This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.(b)(6).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 3.5MM LCP RECONSTRUCTION PLATE 8 HOLES/112MM
• Common Device Name: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): SYNTHES RARON; kanalstrasse west 30; raron CH394 2; SZ CH3942
• MDR Report Key: 6411563
• Report Number: 3006126083-2017-10012
• Device Sequence Number: 10994359
• Product Code: KTT
• UDI-Device Identifier: 10886982169624
• UDI-Public: (01)10886982169624(10)7979081
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K000684
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2017

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: 245.081
• Device Lot Number: 7979081
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/22/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/16/2017
• Supplement Report FDA Received Date: 04/19/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2.7 CORTEX SCREW (PART AND LOT # UNKNOWN, QTY 1); 3.5 CORTEX SCREWS (PART AND LOT # UNKNOWN, QTY 7)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 131