MAUDE Adverse Event Report: SYNTHES USA; ROD, FIXATION, INTRAMEDULLARY

Device Problems Break (1069); Material Fragmentation (1261); Difficult to Remove (1528)

Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369); Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

(b)(6).The exact date of device breakage and non-union is unknown.This report is for one (1) unknown broken locking screw.At this time, the exact part number is unknown, but is likely one of the following three: 04.005.420: 4.0mm ti locking screw w/t25 stardrive 30mm for im nails ¿ hsb: rod, fixation, intramedullary ¿ k103002, 04.005.424: 4.0mm ti locking screw w/t25 stardrive 34mm for im nails ¿ hsb: rod, fixation, intramedullary ¿ k103002, 04.005.430: 4.0mm ti locking screw w/t25 stardrive 40mm for im nails ¿ hsb: rod, fixation, intramedullary ¿ k103002.Without verification of the exact part number and its associated lot, the udi is not available.Per facility, the complainant part is not expected to be returned for manufacturing 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 hardware removal and revision procedure was performed on (b)(6) 2016.The patient presented with non-union; it was then confirmed that one (1) of the implanted 4.0mm titanium (ti) locking screws had broken distally.During the revision, a ti adolescent lateral femoral nail and three (3) screws were removed.A portion of the broken screw remained in situ.The patient was then revised with a proximal femur hook plate.The procedure was completed successfully with a post-operative patient outcome of stable.Concomitant device(s) reported: femoral nail (part: 04.031.934s / lot: unknown / quantity: 1), recon screw (part: 04.031.025 or 04.031.028 / lot: unknown / quantity: 1), locking screws (partial part: 04.005.4xx / lot: unknown / quantity: 2).This report is for one (1) unknown broken ti locking screw.This report is 1 of 1 for com-(b)(4).

Manufacturer Narrative

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.

Event Description

It was reported the non-union and broken screw were discovered on an unknown date via an x-ray.

• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES USA
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5857216
• MDR Text Key: 51495969
• Report Number: 2520274-2016-13989
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103002
• 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: 07/21/2016

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
• Other Device ID Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/21/2016
• Initial Date FDA Received: 08/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/08/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Weight: 64