MAUDE Adverse Event Report: SYNTHES JENNERSVILLE LOCKING BOLT MEASURING DEVICE F/TROCHANTERIC FIXATION NAILS; GAUGE, DEPTH

Catalog Number 357.402

Device Problems Device Slipped (1584); Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Event Description

Device report from synthes (b)(4) reports an event as follows: it was reported that spring ball popped out of the depth gauge during a trochanteric fixation nail (tfn) system procedure.The sleeve kept sliding from the depth gauge core.There was an unknown surgical delay in getting the second depth gauge from the second set.The patient status/outcome is unknown.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Additional narrative: event date: unknown.Device is an instrument and is not implanted or explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(4).The investigation could not be completed; no conclusion could be drawn as no product was received.Device history review: manufacture date: january 19, 2015.The device history record review was reviewed and no issues were found during manufacture that would contribute to the 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.

Manufacturer Narrative

Additional narrative: subject device received; no conclusions could be drawn as the device is entering the complaint system.Device is 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: product investigation evaluation: one of the following was received: locking bolt measuring device for 153mm sleeve, tfn (part 360.255 | lot 7892062 | mfg.Date: january 2015) the returned device shows evidence of regular use during its lifespan.There are cosmetic scratches on the outside body and the ball bearing on the internal slider is missing.The distal hooked tip of the device is undamaged.It is unknown what caused the complaint condition.A visual inspection, functional test, and drawing review were performed as part of this investigation.No product design issues or discrepancies were observed.The associated drawing for the device(s) was reviewed.No drawing issues or discrepancies were noted.The design is adequate for its intended use and did not contribute to this complaint condition.The returned instrument(s) are used to measure screw length during femoral nail implantations and proper use and maintenance are addressed in technique guides.The cause of the complaint condition could not be determined.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: LOCKING BOLT MEASURING DEVICE F/TROCHANTERIC FIXATION NAILS
• 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: 4726202
• MDR Text Key: 5583475
• Report Number: 3003787298-2015-10021
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 357.402
• Device Lot Number: 7892062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2015
• 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