MAUDE Adverse Event Report: SYNTHES MONUMENT 12.0MM OUTER PROTECTION SLEEVEFOR SUPRAPATELLAR - STERILE; NAIL, FIXATION, BONE

Catalog Number 03.010.437S

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem No Code Available (3191)

Event Date 10/12/2016

Event Type  Injury  

Manufacturer Narrative

Exact patient weight is (b)(6).Udi # - (b)(4).Device is an instrument and is not implanted / explanted.Device is not expected to be returned for manufacturer review/investigation.(b)(4).Device history records review was completed for part# 03.010.437s, lot# 9943617.Release to warehouse date: december 8, 2015.Expiration date: october 31, 2017, supplier: (b)(4).No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.

Event Description

It was reported that on (b)(6) 2016 patient underwent initial implantation of a left tibial nail via a suprapatellar approach to treat a tibial fracture.During the procedure, an outer protection sleeve broke into pieces during a surgical procedure.After the nail was implanted, the surgeon withdrew the outer protection sleeve and noted that it had broken into a number of pieces.An additional incision was made and the pieces were retrieved intact.There was a 25 minute surgical delay.It was reported that additional x-rays were taken which showed no pieces remaining in the patient.The surgery was successfully completed and patient outcome was stable.This report is for one (1) 12.0mm outer protection sleeve for suprapatellar - sterile.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Additional information received.The nail was successfully implanted.Concomitant device reported: 10mm proximal bend tibial nail (part # unknown, lot # unknown, quantity of 1).

• Brand Name: 12.0MM 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: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6069751
• MDR Text Key: 58925195
• Report Number: 1719045-2016-10801
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: 03.010.437S
• Device Lot Number: 9943617
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2015
• 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: 20 YR
• Patient Weight: 69