MAUDE Adverse Event Report: SYNTHES (USA); PLATE, FIXATION, BONE

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient information was not provided by the reporter.(b)(4).This report is for one unknown lcp wrist fusion plate.Lot number is unknown.Two possible part numbers were provided by the reporter: part number 02.110.150, brand name--lcp wrist fusion standard bend plate, device product code--hrs, common name--plate, fixation, bone, 510(k) k042355 and part number 02.110.151, brand name--lcp wrist fusion short bend plate, device product code--hrs, common name--plate, fixation, bone, 510(k) k042355.Other¿udi# is unavailable.The subject device is not expected to be returned to the synthes manufacturer for evaluation.The subject device was still implanted in the patient as of the date of this report.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 that a patient fell and fractured his third metacarpal immediately distal to a locking compression plate (lcp) wrist fusion plate, originally implanted on an unknown date.It was reported that the forth (2.7mm) locking screw was noted to have backed out of the fourth locking hole in the plate; secured to the capitate.The plate implanted in the patient's wrist appeared intact; not broken.This was noted in an x-ray taken on (b)(6) 2016.The patient is currently healing from the fracture.It is uncertain if a revision surgery will be performed.This report is for one unknown lcp wrist fusion plate.This report is 2 of 2 for (b)(4).

• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5384283
• MDR Text Key: 36574318
• Report Number: 2520274-2016-10380
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK042355
• 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: 01/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1