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

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 part 03.010.438s lot 7069802: released 08 march 2013.Expiration date 31 january 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 march 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 03.010.437s.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 2 of 2 for (b)(4).

• 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 Key: 5032573
• MDR Text Key: 24141370
• Report Number: 1719045-2015-10539
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK111667
• Number of Events Reported: 1
• 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

• Date FDA Received: 08/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2015
• Device Catalogue Number: 03.010.438S
• Device Lot Number: 7069802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-0404-2014
• Patient Sequence Number: 1