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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES MONUMENT 14.5MM OUTER PROTECTION SLEEVE FOR SUPRAPATELLAR - STERILE; NAIL, FIXATION, BONE

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SYNTHES MONUMENT 14.5MM OUTER PROTECTION SLEEVE FOR SUPRAPATELLAR - STERILE; NAIL, FIXATION, BONE Back to Search Results
Catalog Number 03.010.438S
Device Problem Packaging Problem (3007)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Device is an instrument and is not implanted/explanted.Device history record (b)(4), lot 7069802: released (b)(6) 2013, expiration date (b)(6)2015.(b)(4) manufactured the 14.5mm outer protection sleeve for suprapatellar - sterile.The supplier¿s certificate of compliance indicates the parts were manufactured to and met the required specifications.The lot was inspected to the synthes incoming final inspection sheet.A non-conformance report was created for the incorrect part number documented on the certificate of conformance.The certificate was corrected and returned to synthes, and the non-conformance report was closed.This is a known complaint; returned parts are being controlled.A product investigation was completed: the returned protection sleeves, lot 7069802, were manufactured in (b)(6) 2013.They were both received with no signs of wear.The packaging was not returned thus the complaint condition cannot be replicated and the ¿packaging: wrong product in package¿ portion of the complaint condition is unconfirmed.The inner diameter at the base of the returned sleeves measures approximately 14.40mm and 14.41mm which matches the dimensions of part number (b)(4).Per the device history record, this is a known complaint; returned parts are being controlled.Thus, this possible condition has been addressed.The protection sleeves were manufactured to an older drawing.Therefore, a review of the current edition of the design drawing and the manufactured drawing was performed.It was found that there were no design changes that would affect the functionality of the part.Thus, the current design is suitable for its intended use and the previous design revision did not contribute to the broken driving cap.The ¿no product failure indicated¿ portion of the complaint condition is confirmed.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 there was a labeling issue with two holding sleeves during surgery.It was reported that the surgeon was performing a supra patellar tibia nail procedure.When the holding sleeve was opened, instead of there being a 14.5 mm holding sleeve as the packaging instructed, there was a 12 mm holding sleeve instead.A second 14.5 mm sleeve was opened and instead of a 14.5 mm holding sleeve as the packaging instructed, the package included a 12 mm holding sleeve.A third sleeve was opened and used with no issue.There was no delay in surgery.There was no patient issue.This is report 1 of 2 for (b)(4).
 
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Brand Name
14.5MM OUTER PROTECTION SLEEVE FOR SUPRAPATELLAR - STERILE
Type of Device
NAIL, FIXATION, BONE
Manufacturer (Section D)
SYNTHES MONUMENT
1051 synthes ave
monument CO 80132
Manufacturer (Section G)
SYNTHES MONUMENT
1051 synthes ave
monument CO 80132
Manufacturer Contact
linda plews
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key5032510
MDR Text Key24137531
Report Number1719045-2015-10538
Device Sequence Number1
Product Code JDS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK111667
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Nurse
Remedial Action Recall
Report Date 02/07/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/31/2015
Device Catalogue Number03.010.438S
Device Lot Number7069802
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/27/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/26/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/06/2012
Is the Device Single Use? Yes
Type of Device Usage Unknown
Removal/Correction NumberZ-0404-2014
Patient Sequence Number1
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