MAUDE Adverse Event Report: SYNTHES (USA) 10MM TI CANN TIBIAL NAIL-EX W/PROX BEND 315MM-STERILE; NAIL,FIXATION,BONE

Catalog Number 04.034.443S

Device Problem Separation Failure (2547)

Patient Problem Sedation (2368)

Event Date 10/31/2012

Event Type  Injury  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported after the nail insertion from upper part of the patella, a connecting screw could not be released from the insertion handle.Once the surgeon removed the reported nail out of the patient¿s body the connecting screw could be released outside the patient¿s body.The surgeon changed entry point in the tuberosity of tibia bone and reinserted the nail in question.The operation was extended for 90 minutes.This is report 1 of 3 for (b)(4).

Manufacturer Narrative

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.

• Brand Name: 10MM TI CANN TIBIAL NAIL-EX W/PROX BEND 315MM-STERILE
• Type of Device: NAIL,FIXATION,BONE
• 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: 4321957
• MDR Text Key: 17933761
• Report Number: 2520274-2014-15258
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK040762
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.034.443S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 27 YR
• Patient Weight: 66