MAUDE Adverse Event Report: SYNTHES MEZZOVICO 3.5MM LCP OLECRANON PLATE 8 HOLES/RIGHT/164MM; APPLIANCE, FIXATION, NAIL

Catalog Number	236.508
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.The subject device is not expected to be returned to the synthes manufacturer for evaluation.The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history record review was performed for the subject device lot.Manufacturer: synthes (b)(4).Date of manufacture date: feb 6, 2008.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).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 the patient was originally implanted on an unknown date with one (1) 3.5mm locking compression plate (lcp) olecranon plate and a unknown quantity of unknown screws to treat a olecranon fracture.Post-operatively, the patient presented with a lump over the original fracture site.On (b)(6) 2017 patient underwent revision/explant surgery.During the procedure osteomyelitis was discovered in the bone.Due to the complications of the plate and screws removal an additional 60 minutes was added to operating room time.Patient is reported in stable condition and surgery was completed successfully but with screw fragments being retained.This report addresses the development of osteomyelitis and need for revision surgery.The intraoperative events are addressed and reported in related complaint, (b)(4).This report is 2 of 2 for (b)(4).

• Brand Name: 3.5MM LCP OLECRANON PLATE 8 HOLES/RIGHT/164MM
• Common Device Name: APPLIANCE, FIXATION, NAIL
• Manufacturer (Section D): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• MDR Report Key: 6364141
• Report Number: 1000562954-2017-10021
• Device Sequence Number: 975141
• Product Code: KTT
• UDI-Device Identifier: 10886982160775
• UDI-Public: (01)10886982160775(10)1834058
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K000684
• 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): 02/01/2017

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: 236.508
• Device Lot Number: 1834058
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2017
• Initial Report FDA Received Date: 02/28/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention