MAUDE Adverse Event Report: SYNTHES BRANDYWINE SPECIALTY LOCKING MEASURING DEVICE FOR TI FEMORAL NAILS-EX; GAUGE, DEPTH

Catalog Number 03.010.085

Device Problem Incorrect Measurement (1383)

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

Event Date 02/10/2016

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Dhr review - release to warehouse date: 11dec2007.Supplier: (b)(4).No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.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 during an initial lateral entry femoral nail procedure on (b)(6) 2016, the drill stop for a 4.5mm/6.5mm stepped drill bit did not stop the drill bit.The drill stop kept going and the specialty locking measuring device for the (ti) femoral nails-ex depth gauge was not measuring accurately.The surgeon noticed where he needed to stop drilling, and manually stopped the drill.Additionally, the surgeon measured for the first screw which was 90mm.When he implanted the screw it was 10mm longer than what it was supposed to be.The surgeon pulled the screw out and put the correct size screw in.This caused a one (1) minute surgical time delay.After the procedure, a tape measurer was used to check the screw and the depth gauge.The screw was accurate but the depth gauge was not measuring correctly.There was no patient harm and no additional medical surgical intervention required.The patient's status outcome was reported as stable postoperatively.The procedure was completed successfully.This is report 3 of 3 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.The subject device has been received and is currently in the evaluation process.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

An investigation summary was performed.The investigation of the complaint articles has shown that: 03.010.085: a root cause could not be definitively determined for the measuring device as no functional issue was identified.Technique guide shows proper use of the measuring device and notes that the user ¿ensure the protection sleeve is pressed firmly to the lateral cortex,¿ that the measuring device is inserted ¿over the guide wire into the protection sleeve to the bone¿ and that the 3.2mm guide wire, 400mm (part number 357.399) be used.The device is also etched ¿use with 357.399.¿ -03.010.085: during the investigation no product design issues or discrepancies were observed with the measuring device that may have contributed to the complaint condition and it is consistent with calculated risk assessment occurrence rate.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

Additional narrative: clarification to device investigation summary - one drill stop for 4.5mm/6.5mm stepped drill bit (part number 03.010.079, lot number 5734699) was received and one specialty locking measuring device for titanium femoral nails-expert (part number 03.010.085, lot number 5596096) was received.The overall complaint condition is confirmed as issues were found with the drill stop.Specifically, the condition for the measuring device is unconfirmed as no functional issue was identified.A root cause could not be definitively determined.However, the returned part was determined to be suitable for the intended use when employed and maintained as recommended and the risk assessment was found to adequately address the complaint condition.The complaint condition is confirmed for the drill stop as the condition could be replicated with gage pins.During the investigation for the drill stop it was determined that the plunger component underwent a design change.The design changes updated the mating drill bits and the drill stop to improve engagement.Thus, as the returned device was manufactured prior to this design change, it is probable the complaint condition was a result of a design deficiency.Further device evaluation shows that the devices are used for recon screw insertion.As the reported procedure was a lateral entry femoral nail procedure the titanium cannulated lateral entry femoral recon nail technique guide was reviewed.The measuring device is inserted though the 8.5/3.2mm wire guide to measure for the recon screw length based off the 3.2mm guide wire, 400mm.The drill stop is subsequently used with the 4.5mm/6.5mm stepped drill bit to control the depth of the drill.The measuring device was received intact.The only noted damage was nicks and wear on the edges of the device.The length from the distal end to the 130mm graduation line, the length between each gradation line, and the length of the graduation segment were all found to be conforming to specifications.Thus, as no functional issue was identified, the complaint condition for this device is unconfirmed and could not be replicated.The drill stop was also received intact and showing worn edges.When tested with gage pins, the drill stop would allow an 8.30mm pin to pass without depressing the button on the drill stop and would allow an 8.41mm pin to pass with a light force applied by hand (without depressing the button).The mating drill is specified as 8.4mm +0/-0.03 with a 0.15mm x 45 degree chamfer.Thus, the complaint condition is confirmed as under light force the lock would slip on a diameter greater than the max diameter of the mating device.Thus, the complaint condition is confirmed, consistent with the reported condition, and can be replicated.A review of the current design drawings for both devices was performed.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: SPECIALTY LOCKING MEASURING DEVICE FOR TI FEMORAL NAILS-EX
• Type of Device: GAUGE, DEPTH
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5469865
• MDR Text Key: 39426331
• Report Number: 2530088-2016-10061
• Device Sequence Number: 1
• Product Code: HTJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.085
• Device Lot Number: 5596096
• Other Device ID Number: (01)10886982067555(10)5596096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/29/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23 YR