MAUDE Adverse Event Report: SYNTHES USA 4.9MM TI LOCKING BOLT 34MM; PIN, FIXATION, SMOOTH

Catalog Number 459.340VS

Device Problems Unstable (1667); Unintended Movement (3026)

Patient Problem Non-union Bone Fracture (2369)

Event Type  malfunction  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported the patient was initially implanted with (b)(4) proximal femoral nail anti-rotation on (b)(6) 2015.It noted during follow up visit on (b)(6) 2015, there was instability of the implant.The slight rotation of cranial bone was confirmed.The surgeon continued to observe progress towards to the patient because the patient also showed a sign of synostosis on inside front of the implant region.On (b)(6) 2015, further rotation of cranial bone and the precedence of the blade were seen.This is report 2 of 3 for (b)(4).

Manufacturer Narrative

Event date: unknown.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: 4.9MM TI LOCKING BOLT 34MM
• Type of Device: PIN, FIXATION, SMOOTH
• 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: 4643914
• MDR Text Key: 20128846
• Report Number: 2520274-2015-12400
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK970733
• 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: 03/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 459.340VS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2015
• 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 Age: 82 YR