MAUDE Adverse Event Report: SYNTHES GRENCHEN 4.5MM CURVED BROAD LCP® PLATE 12 HOLES/229MM; PLATE,FIXATION,BONE

Catalog Number 226.622

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient age and weight are not available for reporting.Event date: unknown.Additional device product code is hwc.(therapy date): implant date is unknown.The subject device is not expected to be returned to the synthes manufacturer for evaluation.The subject device was reportedly discarded by the reporting hospital.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 complaint device lot.Manufacturing location: (b)(4).Manufacturing date: mar 20, 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 complaint 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 Description

It was reported the patient had an angulated leg, nonunion, and plate breakage which required revision surgery.The patient was initially implanted with one (1) 4.5mm curved broad locking compression plate (lcp) 12 holes/229mm and unknown quantity of locking screws and cortical screws approximately four weeks prior to the date of this report (exact date is unknown).The patient was non-compliant and walked on her leg.The patient then noticed her leg was angulated.The patient did not report any pain and came back for a non-routine visit on (b)(6) 2017.X-rays taken during the visit confirmed that the plate broke.The patient was revised on (b)(6) 2017.The devices were easily removed and did not require additional medical intervention.The screws were removed intact.No fragments generated from the broken plate.The patient was revised to a 4.5mm lcp condylar plate and femoral strut graft with cables.The revision surgery was successfully completed without surgical delays.The patient status/outcome was reported as unstable.Concomitant devices reported: unknown locking screws (part # unknown, lot # unknown, quantity # unknown), unknown cortical screws (part # unknown, lot # unknown, quantity # unknown) this report is 1 of 1 for (b)(4).

• Brand Name: 4.5MM CURVED BROAD LCP® PLATE 12 HOLES/229MM
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES GRENCHEN; solothurnstrasse 186; grenchen CH254 0; SZ CH2540
• Manufacturer (Section G): SYNTHES GRENCHEN; solothurnstrasse 186; grenchen CH254 0; SZ CH2540
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6312862
• MDR Text Key: 66860132
• Report Number: 3009450884-2017-10021
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982159168
• UDI-Public: (01)10886982159168(10)9406756
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082807
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/17/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: 226.622
• Device Lot Number: 9406756
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/17/2017
• Initial Date FDA Received: 02/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNKNOWN CORTICAL SCREWS, QUANTITY UNKNOWN; UNKNOWN LOCKING SCREWS, QUANTITY UNKNOWN
• Patient Outcome(s): Required Intervention