MAUDE Adverse Event Report: SYNTHES USA 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 34MM FOR IM NAILS; SCREW, FIXATION, BONE

Catalog Number 04.005.524

Device Problems Device Markings/Labelling Problem (2911); Device Packaging Compromised (2916)

Patient Problem No Code Available (3191)

Event Date 05/15/2016

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient weight not available for reporting.Date of event: unknown.(b)(4).Implant and explant dates are unknown.Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.(b)(4): one (1) 5.0mm titanium locking screw noted to be the wrong size diameter and wrong anodized color during a surgical procedure.The malfunction of incorrect packaging led to additional intervention during the procedure to confirm the size of the screw's diameter by x-ray.In addition, the screw had to be removed, and a screw of the correct size was implanted in its place.Subject device has not been 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

It was reported that during an implant of a tibial nail on (b)(6) 2016 the surgeon pre-drilled an appropriate sized hole for a 5.0mm screw and noted that the screw, once placed spun around.The surgeon took and x-ray and it was confirmed that the screw diameter looked smaller than the second screw that was implanted.The reporter asked the surgical staff to confirm that the screw was a blue anodized screw (5mm) and not a green anodized screw (4mm) and the staff confirmed that it was blue prior to being placed.As the screw diameter appeared in the x-ray image to be smaller, the screw was removed and another 5mm blue anodized screw was implanted without issue.When the screw was removed it was confirmed to be blue but the screw size was confirmed to be 4mm instead of 5mm as expected.The reporter deduced that the screw more than likely was packaged as a 5mm screw because it was stocked per packaging and color.The screw was removed and the correct screw was implanted in its place.There was no additional surgical intervention was required, no impact to the patient, surgery was delayed for about ten minutes; the time it took to remove and replace the incorrect screw with he correctly sized implant.The successfully completed with the patient being noted as stable after surgery.This complaint involves one (1) device.This report is 1 of 1 for (b)(4).

Manufacturer 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 not implanted/explanted.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

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

Updated information: july 12, 2016 - it was reported that the reporter asked the surgical staff to confirm that the screw was a green anodized screw (5mm) and not a blue anodized screw (4mm) and the staff confirmed that it was green prior to being placed.As the screw diameter appeared in the x-ray image to be smaller, the screw was removed and another 5mm, green anodized screw was implanted without issue.When the screw was removed it was confirmed to be green in color but the screw size was confirmed to be 4mm instead of 5mm as expected.

Manufacturer Narrative

A manufacturing investigation & invest.Summary was conducted.One 5.0mm ti locking screw w/t25 stardrive 34mm for im nails (part#04.005.524 lot unknown) was received at customer quality (cq) for evaluation with complaint category "appearance /state not as expected: wrong color" and with complaint description "it was reported that during an implant of a tibial nail on (b)(6) 2016 the surgeon pre-drilled an appropriate sized hole for a 5.0mm screw and noted that the screw, once placed spun around.The surgeon took and x-ray and it was confirmed that the screw diameter looked smaller than the second screw that was implanted.No lot number was made available therefore the dhr could not be reviewed nor could inventory be evaluated.Part number 04.005.524 is manufactured in the (b)(4), co facility.Part number 04.005.524 is a ø5.0 mm ti locking screw with t25 stardrive, 34mm and is anodized light green for color identification.Part number 04.005.424 is a ø4.0mm ti locking screw with t25 stardrive, 34mm and is anodized blue for color identification.The report indicates that the: the complaint screw diameter measures ø3.92.The flutes were also examined and the flutes are shallow and short.The screw was anodized light green.Most likely a 04.005.424 screw (ø4mm) was mixed with a lot of 04.005.524 (ø5mm) screws.The ø4mm screw was then anodized light green with the ø5mm screws.The process flow for both 04.005.524 and 04.005.424 is as follows: whirl threads - vibrate - flute - ultrasonic clean - anodize - final inspection - pack/label - release to warehouse.The product mix most likely did not occur at the whirl threads operation because the machine would reject the ø4mm screw when program was set to thread ø5mm screws.The ø4mm screw did most likely get mixed with the ø5mm lot at the vibrate operation.At this operation parts are put into the vibe bowl with media and then spun.Upon completion parts are separated from media using a screen.It is possible that line clearance was not 100% effective as this is a manual operation.The ø4mm part would then have traveled with the ø5mm parts to the flute operation.Flutes were present on the ø4mm screw but were not correct.Flutes were shallow and short which is also another indicator that shaft diameter was not correct when processed to the fluting operation.The incorrect diameter would result in incorrect flutes since machine program was set for ø5mm screw.The following process controls are in place to detect occurrences of this nonconformance type: this complaint is confirmed.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.

• Brand Name: 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 34MM FOR IM NAILS
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5688847
• MDR Text Key: 46209624
• Report Number: 2520274-2016-12923
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK000089
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.005.524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2016
• 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
• Patient Age: 43 YR