MAUDE Adverse Event Report: SYNTHES USA DEPTH GAUGE FOR 2.7MM & SMALL SCREWS; GAUGE, DEPTH

Catalog Number 319.04

Device Problem Incorrect Measurement (1383)

Patient Problem Sedation (2368)

Event Date 07/21/2015

Event Type  Injury  

Event Description

It was reported that during a wrist fusion surgery, it was noted that a depth gauge was not assembled correctly.Another depth gauge was inserted into the first depth gauge which threw off all measurements for screw length.There were six (6) screws that were implanted and had to be removed due to being too long, secondary to these measurements.There was no malfunction with the screws.There was a thirty (30) minute surgical delay.No further patient harm was reported and surgery was completed successfully.The procedure was a revision procedure involving a non-synthes implant that had been implanted thirty (30) years ago.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

Additional narrative: (b)(6).Patient weight is unknown.Device is an instrument and is not implanted/explanted.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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

No service history review can be performed because the lot number is unknown and cannot be traced.The mfr date is unknown.The service history eval is unconfirmed.Device was used for treatment, not diagnosis.If info is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Subject device has been received; no conclusions could be drawn as the device is entering the complaint system.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

The device was returned to the customer prior to the completion of an evaluation.Therefore, no investigation information/results are available for reporting.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.Returned to customer prior to evaluation.

• Brand Name: DEPTH GAUGE FOR 2.7MM & SMALL SCREWS
• Type of Device: GAUGE, DEPTH
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4974437
• MDR Text Key: 18652907
• Report Number: 2520274-2015-15127
• 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,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 319.04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/09/2015
• Was Device Evaluated by Manufacturer?: No
• 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 Outcome(s): Required Intervention
• Patient Age: 50 YR