MAUDE Adverse Event Report: SYNTHES USA DEPTH GAUGE FOR LARGE SCREWS; GAUGE, DEPTH

Catalog Number 319.10

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported that several devices were discovered to be broken or damaged during sterile processing.The needle for three (3) depth gauges for 2.0mm and 2.4mm screws had broken off.Additionally, it was discovered that the head pieces and collars were missing from two other devices (depth gauges for 2.7mm and small screws and depth gauges for large screws).The events did not occur during a procedure and, therefore, resulted in no patient harm or surgical delay.This report is 5 of 5 for com-(b)(4).

Manufacturer Narrative

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 completed.The investigation could not be completed; no conclusion could be drawn as no product was received.A review of the service history records has been requested and is pending completion.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

Service history review: no service history review can be performed because the lot number is unknown and cannot be traced.The manufacture date is unknown.The service history evaluation is unconfirmed.A product investigation was completed: depth gauge-1 (part 319.01 | lot 8080549 | manufacture date: 10/2012); depth gauge-2 (part 319.006 | lot 6138150 | manufacture date: 05/2009); depth gauge-3 (part 319.006 | lot 6770210 | manufacture date: 09/2011); depth gauge-4 (part 319.006 | lot 7151460 | manufacture date: 09/2013)the returned depth gauges show signs of regular usage, with various scratches and marks.Gauge-1 has no functional damage but is missing the headpiece/pin assembly.Component was most likely lost during sterile processing.Remaining devices (gauge-2, gauge-3, and gauge-4) have the measuring needle broken off at their interface to the black graduated rod.This damage most likely occurred during sterile processing.A visual inspection, dimensional inspection, functional test, complaint history review, drawing review, and risk assessment review were performed as part of this investigation.This complaint is confirmed.The drawing for the device(s) were reviewed.No drawing issues or discrepancies were noted.The designs are adequate for their intended use and did not contribute to this complaint condition.The returned instrument(s) are additional instruments used during implantations to measure screw sizes and proper use and maintenance are addressed in numerous technique guides.Although the exact cause cannot be determined, this complaint condition is possibly a result of method of use and inattentiveness during sterilization.An inspection of the returned components showed no design issues.The returned part(s) are determined to be suitable for their intended use when used and maintained as recommended.This complaint is confirmed, but the design of the device did not contribute to this complaint.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

Service & repair evaluation: the customer reported the head piece and collar were missing.The repair technician reported missing parts as the reason for repair.The cause of the issue is unknown.The following parts were replaced: knurled cap, head piece.This item was repaired, passed synthes final inspection, and returned to the customer on may 14, 2015.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: DEPTH GAUGE FOR LARGE SCREWS
• Type of Device: GAUGE, DEPTH
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES USA
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4748002
• MDR Text Key: 5709532
• Report Number: 2520274-2015-13592
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 319.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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