MAUDE Adverse Event Report: SYNTHES ELMIRA LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 6 HOLES/69MM; PLATE,FIXATION,BONE

Catalog Number	241.361
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.A device history record review was performed for the subject device lot number 9804737.Manufacturing location: synthes (b)(4).Date of manufacture: 07-may-2015.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.(b)(4).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 had an open reduction internal fixation revision surgery of the fibula.All existing hardware was removed due to failure of reduction, with no malfunction of product.This could of possibly been caused by the patient weight bearing too soon.Patient had new hardware implanted at time of revision, a 5 hole right 2.7mm variable angle(va) locking compression plate (lcp) and unknown number of va locking screws and unknown number of 3.5mm cortical screws.The quantity of screws total is six (6).There was no delay in surgery.Patient's outcome is unknown.This report is 1 of 3 for (b)(4).

• Brand Name: LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 6 HOLES/69MM
• Common Device Name: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• MDR Report Key: 6572787
• Report Number: 3003506883-2017-10083
• Device Sequence Number: 13475750
• Product Code: HRS
• UDI-Device Identifier: 10886982166876
• UDI-Public: (01)10886982166876(10)9804737
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K011335
• 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): 04/19/2017

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 Catalogue Number: 241.361
• Device Lot Number: 9804737
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2017
• Initial Report FDA Received Date: 05/17/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Weight: 122