MAUDE Adverse Event Report: SYNTHES JENNERSVILLE DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS; GAUGE, DEPTH

Catalog Number 319.006

Device Problem Sticking (1597)

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

Event Date 10/19/2015

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: patient information was not provided by reporter.(b)(4).Device is an instrument and is not implanted/explanted.The subject device has been received and is currently in the evaluation process.A device history record review has been requested and the results are pending.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 a star drive screwdriver was damaged during an elbow case and would not engage the 2.7 variable angle locking star head screws.A back up screw driver was used and it too exhibited the same intraoperative device failure.It was additionally reported that while attempting to use the aforementioned screw drivers, three (3) of the 2.7 variable angle screws used during the surgery would not engage or lock into three (3) of the proximal holes of the olecranon plate.While using one of the reported screw drivers another screw would not lock into the posterior lateral tab hole of a second plate as well.Two backup, t8 screw drivers shafts were retrieved from a distal radius set and used to complete the surgery.The three stripped screws inserted into the olecranon plate were left in the plate despite not being fully locked in the plate.It was additionally reported that the one screw that would not lock into the posterior lateral tab hole of the second plate was removed and not replaced with another screw.The reporter stated that there were other screws in place to secure both plates.During the same surgical procedure it was noted that the depth gauge in the same set was very sticky.The surgery was successfully completed with no surgical delay or patient injury reported.This report is for the depth gauge that was very sticky during the surgery.This report is 3 of 3 for (b)(4).

Manufacturer Narrative

Part number: 319.006, lot number: 7363440: release to warehouse date: 02may2013.Manufactured by synthes (b)(4).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 this product that would contribute to this complaint condition.A product investigation was completed: one depth gauge for 2.0mm and 2.4mm screws (part number: 319.006, lot number: 7363440, manufacture date: 02may2013 was received.Upon functional testing of the complaint device, the complaint condition could not be replicated, there is no indication of the depth gauge become stuck when being removed from its protective cover.The observed complaint condition at the time of the event may have been caused by the buildup of bioburden during its lifespan and once it was sterile processed by synthes, the buildup was removed and therefore the complaint cannot be confirmed.Per the technique guide, the device can be used in 2.7mm/3.5mm variable angle lcp elbow system.The t8 screwdriver shafts are used to insert 2.7mm screwdrivers onto the plate and the depth gauge is used to determine the screw length to be used for the procedure.The returned instrument was examined and the complaint condition was unable to be replicated as the depth gauge functioned as intended and operated smoothly.The complaint is unconfirmed.As no product faults were found with the returned implant, no further investigation is required.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: DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS
• Type of Device: GAUGE, DEPTH
• Manufacturer (Section D): SYNTHES JENNERSVILLE; 108 willowbrook lane; west chester PA 19382
• Manufacturer (Section G): SYNTHES JENNERSVILLE; 108 willowbrook lane; west chester PA 19382
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5214233
• MDR Text Key: 30886412
• Report Number: 3003787298-2015-10041
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 10/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 319.006
• Device Lot Number: 7363440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2013
• 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