MAUDE Adverse Event Report: SYNTHES MEZZOVICO VA-LCP CONDYLAR PLATE 4.5/5.0 R 16HO L33; IMPLANT,FIXATION DEVICE,CONDYLAR PLATE

Catalog Number 02.124.416S

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 08/10/2017

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not diagnosis.Patient id, dob and weight not provided for reporting.(b)(4).This report is for unk - plate condylar/unknown lot number.Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.Without a lot number, the device history record review and 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

Device report from synthes on an event in (b)(6) as follows: it was reported that the patient had a knee and hip replacement because the patient suffered a fracture in the distal third of the femur.The surgeon placed a va-lcp plate with five locking screws distally on (b)(6) 2017.The plate broke through the open locking hole, that was over the fracture on (b)(6) 2017.The plate was removed and another plate was implanted on (b)(6) 2017.This complaint involves 1 part.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(6).Corrected data: address.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Additional product codes: hrs, hwc we have forwarded the received va-lcp condylar plate 4.5/5.0 r 16ho l33 (02.124.416s / 9903348) to the responsible manufacturing site for investigation, here is the statement: upon visual inspection of the complaint device it can be seen that the plate is broken at level of va5 hole, this thus confirming the complaint description.A device history record (dhr) review was performed for the affected lot, 11 parts were delivered to the warehouse, no abnormalities or deviations were detected, which could lead to the complaint failure.The article was manufactured in april 2016.No ncrs were marked in the dhr during production.Moreover a review of our complaints data base shows, that there are no other complaints for this issue from this article and lot number.The plate is broken at the level of the hole va5 and damaged post production at level of holes va1 and va4.The holes va-2/3/6/7 (the ones closest to fracture) were found conforming to specification for features that are still measurable.For these features, since the va-holes are manufactured using the same cnc program and tools (repeated features), it is possible to conclude that all variable angles holes were conforming to spec.The plate thickness and with were measured in different points of the plate and found in specification.No evidence of non-conformance manufacturing related.The raw material has been verified through review of certificate documented in the dhr review section.Considering that all relevant measurable product features meet specification and no visual defects manufacturing related have been identified on returned item, the conclusion of the product investigation is that the returned part is conforming from a manufacturing perspective.Manufacturing evaluation is disposed as confirmed due to evidence that part is broken, but it's considered not valid for the manufacturing side because there is no evidence of issues manufacturing related.No manufacturing related issue was identified.Unfortunately we are not able to determine the exact reason for this occurrence.Furthermore, we have also received a few concomitant parts, see list below: nine (9) va locking screws self tapping, two (2) locking screws self tapping, one (1) va periprosthetic locking screw, one (1) cortex screw selp tapping, as those parts are not responsible for the breakage of the plate, no further investigation will be done.X-ray review -> we are able to confirm that we see a broken plate, but no finding.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.

Event Description

It was reported that the patient had a knee and hip replacement.Afterward, patient suffered a fracture in the distal third of the femur.The surgeon placed a variable angle-locking compression (va-lcp) plate with five (5) locking screws and two (2) cables proximally and six (6) locking screws distally on (b)(6), 2017.The plate broke through the open locking hole, that was over the fracture.The plate was removed and a long distal fibula (df) plate was implanted on (b)(6), 2017.

Manufacturer Narrative

Device used for treatment, not diagnosis.Udi: (b)(4).Returned to manufacturer: sep 26, 2017.A device history record review was performed for the subject device lot number 9903348.Manufacturing location: (b)(4).Date of manufacture: apr 21, 2016.Expiration date: apr 1, 2026.The review showed that there were no issues during the manufacture or sterilization of the product that would contribute to this complaint condition.No non-conformances were generated during the production or sterilization of the subject device.A manufacturing investigation was performed for the subject device: part not received in the original packaging: the p/n and lot number etched on products match to complaint system and dhr.The returned plate was re-inspected for all the features pertinent to the complaint condition according to the product investigation matrix ¿broken/cracked¿ reported in the procedure.The plate is broken at the level of the hole va5 and damaged post production at level of holes va1 and va4.The holes va-2/3/6/7 (the ones closest to fracture) were found conforming to specification for features that are still measurable.For these features, since the va-holes are manufactured using the same cnc program and tools (repeated features), it is possible to conclude that all variable angles holes were conforming to spec.The plate thickness and with were measured in different points of the plate and found in specification.No evidence of non conformance manufacturing related.Considering that all relevant measurable product features meet specification and no visual defects manufacturing related have been identified on returned item, the conclusion of the product investigation is that the returned part is conforming from a manufacturing perspective.Mia is disposed as confirmed due to evidence that part is broken, but it's considered not valid for mezzovico because there is no evidence of issues manufacturing related.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Concomitant medical products: 1x 02.231.275 /l242468 va lockscr ø5 self-tap l75 sst /9903348, 1x 02.231.280 /l197482 va lockscr ø5 self-tap l80 sst, 1x 02.231.265 /9763900 va lockscr ø5 self-tap l65 sst, 1x 02.231.255 /9889384 va lockscr ø5 self-tap l55 sst, 1x 02.231.232 /9638269 va lockscr ø5 self-tap l32 sst, 1x 02.231.240 /8926611va lockscr ø5 self-tap l40 sst, 1x 02.231.240 /l201807 va lockscr ø5 self-tap l40 sst, 1x 02.221.460 /2286257 lockscr ø5 self-tap l10 sst, 1x 02.231.014 /9466256 va periprosthetic lock screw ø5 self-tap, 1x 214.848 /l205079 cortscr ø4.5 self-tap l48 sst, 1x 222.402s /9632526 lockscr ø5 self-tap l14 sst, 1x 02.231.270 /l170105 va lockscr ø5 self-tap l70 sst, 1x 02.231.280 /l121877 va lockscr ø5 self-tap l80 sst.

• Brand Name: VA-LCP CONDYLAR PLATE 4.5/5.0 R 16HO L33
• Type of Device: IMPLANT,FIXATION DEVICE,CONDYLAR PLATE
• Manufacturer (Section D): SYNTHES MEZZOVICO; zona industriale 4; mezzovico PA CH680 5; SZ CH6805
• Manufacturer (Section G): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6846754
• MDR Text Key: 85102764
• Report Number: 2520274-2017-12219
• Device Sequence Number: 1
• Product Code: JDP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.416S
• Device Lot Number: 9903348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR