MAUDE Adverse Event Report: SYNTHES GRENCHEN TI LCP PROXIMAL LATERAL TIBIA PL 11 HOLES/260MM-RIGHT; PLATE, FIXATION, BONE

Catalog Number	422.226
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Nonunion/Delayed-union Bone Fracture (2369); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Patient height is (b)(6) cm.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: jul 22, 2016.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 underwent revision surgery on (b)(6) 2017 for removal of hardware due to infection and a delayed union.The patient was originally implanted with one (1) titanium locking compression plate-proximal lateral tibia and eight (8) screws on (b)(6) 2017 during an open reduction internal fixation (orif) of the tibia to treat a fracture.On an unknown date after the surgery the patient developed an infection and a mass formed at his knee.It is unknown whether the patient had pain related to the diagnosis or when he sought medical attention.During the revision the plate and eight (8) screws were removed whole and intact and the mass at the patient¿s knee was drained, irrigated and debrided.The patient received antibiotics.New hardware was not implanted.There was no surgical delay.No harm was reported to the patient.The procedure was successfully completed.This report is 1 of 9 for com-(b)(4).
Additional Manufacturer Narrative
(b)(6).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.

• Brand Name: TI LCP PROXIMAL LATERAL TIBIA PL 11 HOLES/260MM-RIGHT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GRENCHEN; solothurnstrasse 186; grenchen CO CH254 0; SZ CH2540
• MDR Report Key: 6540682
• Report Number: 1719045-2017-10387
• Device Sequence Number: 10766163
• Product Code: HRS
• UDI-Device Identifier: 10886982215147
• UDI-Public: (01)10886982215147(10)L067497
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K052390
• 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,Followup
• Report Date (Section B): 04/09/2017

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: 422.226
• Device Lot Number: L067497
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/09/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/03/2017
• Supplement Report FDA Received Date: 06/02/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 56