MAUDE Adverse Event Report: SYNTHES USA 2.0MM TI ELASTIC NAIL 440MM; PIN, FIXATION, SMOOTH

Catalog Number 475.920

Device Problem Bent (1059)

Patient Problem Sedation (2368)

Event Date 06/19/2015

Event Type  Injury  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that the surgeon mounted a titanium elastic nail (ten) to the inserter prior to inserting the nail into the medullary canal of the patient¿s bone.The nail was releasing from the inserter, so the surgeon tightened it.When attempting to introduce the nail into the patient¿s bone, however, it was discovered that the nail had bent.It would not release from the inserter.The instrument and nail were switched out for other parts.The procedure was prolonged by thirty (30) minutes.No additional information is available at this time.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

(b)(6).Patient date of birth/age and weight are unknown.Device bent intra-operatively and was not implanted or explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).Investigation could not be completed and no conclusion could be drawn as no device was returned.Without a lot number, the device history record review could not be requested.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.

• Brand Name: 2.0MM TI ELASTIC NAIL 440MM
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES USA
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4881978
• MDR Text Key: 6044270
• Report Number: 2520274-2015-14752
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: PK971783
• 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: 06/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 475.920
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/21/2015
• Initial Date FDA Received: 07/01/2015
• 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