MAUDE Adverse Event Report: SYNTHES MEZZOVICO 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/80MM; IMPLANT,FIXATION DEVICE, CONDYLAR PLATE

Catalog Number 02.231.280

Device Problems Break (1069); Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/13/2015

Event Type  Injury  

Manufacturer Narrative

Additional product codes ¿ hrs, hwc.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(4).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.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 during a revision surgery on (b)(6) 2015 scheduled to replace five (5) backed out screws additional product malfunctions were noted which required additional medical intervention and caused a significant surgical delay.The original surgical plan was to replace only five (5) distal locking screws that had backed out of a variable angle (va) condylar plate.It was reported that the surgeon removed all backed out screws from the construct and continued with the operative plan which was to use the original plate, implanted on (b)(6) 2015, simply replacing with new distal screws.As the surgeon proceeded to place the second distal locking screw, he noted that the second screw continued to spin into the plate without locking.Upon inspection of the threaded end of the screws they were noted to be damaged; the treads were worn away and some portions of the screws that were supposed to be threaded were flat.The surgeon continued to have difficulty locking the screws into the plate, therefore the surgeon examined the distal end of plate and found that the plate was damaged and could not be used.Deducing that the plate was the source of the malfunction, the surgeon subsequently removed the partially implanted plate.Explanting the plate from the shaft involved making additional incisions to remove the partially implanted plate and six screws that were already affixed to the bone.The surgeon had to re-fixate provisionally the new plate, reducing the fracture and use a new set of screws to implant the plate.It was noted that two (2) additional screws, which were reported to have no product problem reported, were also removed.Additional medical intervention was required as coupled with the intraoperative events reported the patient's physiology made it necessary that the surgeon make extra incisions to remove the plate.Additionally, extra fluoroscopy and extended anesthesia was required as the surgery was delayed between 3 to 4 hours.This report addresses the intra-operative issues; the patient's revision surgery is captured in (b)(4).This is report 1 of 4 for (b)(4).

Manufacturer Narrative

It was documented on (b)(6) 2015 that the device was returned on (b)(6) 2015.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.A review of the device history records has been requested.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

Product investigation summary: eight (8) screws and one (1) variable angle-locking compression plate (va-lcp) curved condylar plate were returned.The received plate contained scratches near the distal end and contained damaged distal thread holes.The original implanted screws may have damaged the locking plate hole while backing out, no longer allowing new screws to lock into the plate.It is unknown which of the returned 02.231.280 screws were reportedly backing out.The complaint for the five distal locking screws backing out of the threaded plate hole post-op is captured in (b)(4).The following devices were returned: 4.5mm variable angle lcp curved condylar plate (part# 02.124.417 | lot# 9489247), 5.0mm variable angle locking screw ¿ 26mm length (part# 02.231.226 | lot# 9205632), 5.0mm variable angle locking screw ¿ 80mm length (part# 02.231.280 | lot# 9638264), 5.0mm variable angle locking screw ¿ 70mm length (part# 02.231.270 | lot# 9557501), 5.0mm variable angle locking screw ¿ 75mm length (part# 02.231.275 | lot# 9589404), 5.0mm variable angle locking screw ¿ 36mm length (part# 02.231.236 | lot# 9589404), 5.0mm variable angle locking screw ¿ 80mm length (part# 02.231.280 | lot# 9638264), 4.5mm cortex screw ¿ 36mm length (part# 214.836 | lot# unk), 4.5mm cortex screw ¿ 40mm length (part# 214.840 | lot# unk).The technique guide and product drawings were reviewed during the investigation.The 4.5mm va-lcp curved condylar system is designed to allow screws to be angled anywhere within a 30° cone around the central axis of the hole.The screw position and length should be confirmed prior to final tightening.Additionally, the final tightening must be done manually using a 6nm torque limiting handle.If the original implanted screws were locked at an angle, the backing out of the screws could have caused material from the locking plate hole to be removed or damaged, which would no longer allow new screws to lock.A definitive root cause could not be determined, but no design-related issues were noted during the investigation.Device history record review: manufacturing location: (b)(4) - manufacturing date: september 9, 2015.No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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.

• Brand Name: 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/80MM
• 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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5185340
• MDR Text Key: 29791524
• Report Number: 2520274-2015-16875
• 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: 10/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.231.280
• Device Lot Number: 9638264
• Other Device ID Number: (01)10886982062239(10)9638264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Weight: 110