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

Catalog Number 03.010.438S

Device Problem Mechanical Jam (2983)

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

Event Date 07/19/2015

Event Type  malfunction  

Event Description

It was reported that a surgeon was using the supra-patellar tibial nail during a case and he was having problems with the protection sleeve.Surgeon was using a competitor reaming system which kept catching on the synthes protection sleeve which would then pull out from the incision.Also, the rubber protection sleeve loosened from the protection sleeve handle.Four parts where involved in the reported event, however was not certain which one(s) contributed to this issue.There was a 14 to 30 minute surgical delay due to the reported event.The procedure was successfully completed.This report is 4 of 4 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: patient id (b)(6).Patient weight was not provided by reporter.Device is an instrument and is not implanted/explanted.A device history record review was performed for the subject device lot.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Device was used for treatment, not diagnosis.The expiration date of the subject device per the updated device history record review is february 2016.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 14.5MM OUTER PROTECTION SLEEVEFOR 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: 4956908
• MDR Text Key: 6250943
• Report Number: 1719045-2015-10484
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/19/2015

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 Date: 02/01/2016
• Device Catalogue Number: 03.010.438S
• Device Lot Number: 7599949
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/03/2015
• Initial Date FDA Received: 07/31/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 48 YR