MAUDE Adverse Event Report: SYNTHES (USA); IMPLANT, FIXATION DEVICE, CONDYLAR PLATE

Device Problems Migration or Expulsion of Device (1395); Material Deformation (2976)

Patient Problems Failure of Implant (1924); Pain (1994); Discomfort (2330); Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

This report is for three unknown 5.0mm variable angle locking screws.Part and lot numbers were not provided by reporter.Other¿udi# is unavailable.The exact date of initial implant is unknown and was reported as an unknown date in (b)(6) 2015.The subject devices are expected to be returned to the synthes manufacturer for evaluation.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 three 5.0mm va (variable angle) locking screws (two most distal screws and a center head screw) backed out of a 12-hole va-lcp (variable angle locking compression plate) curved condylar plate.The two proximal head screws were fine.The plate and five screws were originally implanted on an unknown date in (b)(6) 2015.The patient was said to be non-compliant by walking and ultimately falling.Revision was scheduled due to implant failure (loosening), non-union, and pain, irritation, and discomfort.It appeared the threads in the two distal holes were slightly stripped.The va-lcp curved condylar plate was replaced with a lcp curved condylar plate on (b)(6) 2015.The surgery was successfully completed with no surgical delay.This report is for three unknown 5.0mm variable angle locking screws.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

Additional narrative: the device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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.

Manufacturer Narrative

Although it is unknown which three (3) screws backed out, there are five (5) possible part numbers with information listed below: part 02.231.285: 5.0mm va lockng screw/slf-tpng/strdrv/85mm ¿ jdp/hrs/hwc ¿ k110354, part 02.231.280: 5.0mm va lockng screw/slf-tpng/strdrv/80mm ¿ jdp/hrs/hwc ¿ k110354, part 02.231.270: 5.0mm va lockng screw/slf-tpng/strdrv/70mm ¿ jdp/hrs/hwc ¿ k110354, part 02.231.238: 5.0mm va lockng screw/slf-tpng/strdrv/38mm ¿ jdp/hrs/hwc ¿ k110354, part 02.231.236: 5.0mm va lockng screw/slf-tpng/strdrv/36mm ¿ jdp/hrs/hwc ¿ k110354.Product investigation summary: a total of eleven (11) implants were received.All implants were intact and functionally undamaged.There were no issues found with any of them.The locking screws were tested in the locking holes on the head portion of the plate and all holes/locking screws functioned as intended.The exact cause for the complaint condition cannot be determined, but it was likely that the construct was subjected to excessive force due to the noncompliant patient.A visual inspection, functional test, and drawing review were performed as part of this investigation.No product design issues or discrepancies were observed.The relevant drawings for the device(s) were reviewed.No drawing issues or discrepancies were noted.The designs were determined to be suitable for the intended use when employed and maintained as recommended.Device 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.

• Type of Device: IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
• 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: 5366540
• MDR Text Key: 35962276
• Report Number: 2520274-2016-10222
• Device Sequence Number: 1
• Product Code: JDP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK110354
• 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,Followup,Followup
• Report Date: 12/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention