MAUDE Adverse Event Report: SYNTHES USA; PIN,FIXATION,SMOOTH

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Perforation (2001); No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.This report is for one unknown blade, unknown lot number.Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that a dr.Realized a case with (tfna) trochanteric femoral nail during the (mpe) market preference evaluation of this product.In the mpe form handed on (b)(6) 2014, stated that "while bringing in the blade, the k-wire was protruded into the acetabulum," a surgical delay was noted; the report does not specify the amount of time the surgery was delayed.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

(b)(4): device is an instrument and not implanted/explanted.(b)(4): this report is for one k-wire, part and lot numbers unknown.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report was received from (b)(6).This report is for one unknown k-wire.

• 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: 4301187
• MDR Text Key: 19045215
• Report Number: 2520274-2014-15109
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/10/2014

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2014
• Initial Date FDA Received: 12/05/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention