MAUDE Adverse Event Report: SYNTHES USA TI END CAP T25 STRDRV 0MM EXT HUMERAL NAIL-EX SPIRAL BLADE; NAIL, FIXATION, BONE

Catalog Number 04.001.000

Device Problems Loose or Intermittent Connection (1371); Unintended Movement (3026)

Patient Problems Pain (1994); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

(b)(6).Patient date of birth/age and weight are unknown.Exact date of symptom onset and device loosening is unknown.(other): partial udi number: (b)(4) lot unknown the original implant procedure was performed on an unknown date in (b)(6) 2016.Although the complainant part was removed during the revision on (b)(6) 2016 in order to re-position the nail, it was then re-inserted to complete the procedure.The complainant part is not expected to be returned for manufacturer review/investigation.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.

Event Description

It was reported that a patient underwent a revision procedure on (b)(6) 2016 due to unintended movement (back out) of a spiral blade from a humeral nail.The patient was originally implanted with hardware earlier in (b)(6) 2016.However, x-rays taken on (b)(6) 2016 revealed that the titanium (ti) end cap had come loose, which resulted in the spiral blade backing out of the solid humeral nail.During the revision, the surgeon repositioned the nail after removing the blade, the end cap, and a locking screw.The nail and end cap were re-used, but a new locking screw and blade were inserted to complete the procedure.There was no reported delay or additional intervention required.The patient was reportedly stable post-operatively.Concomitant device(s) reported: locking screw (part/lot: unknown / quantity: 1) and humeral nail (part: 462.722 / lot: unknown / quantity: 1).This report is 2 of 2 for (b)(4).

• Brand Name: TI END CAP T25 STRDRV 0MM EXT HUMERAL NAIL-EX SPIRAL BLADE
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES USA
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5869158
• MDR Text Key: 51858594
• Report Number: 2520274-2016-14038
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.001.000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2016
• 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
• Treatment: UNKNOWN LOCKING SCREW
• Patient Outcome(s): Required Intervention