MAUDE Adverse Event Report: SYNTHES USA; WIRE, SURGICAL

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/01/2015

Event Type  Injury  

Manufacturer Narrative

Patient weight is unknown.The original implant procedure was performed on (b)(6) 2015.It is possible that the lodging of the guide wire into the femoral head occurred at that time.As such, the date has been included in the associated field.This report is for one (1) unknown 3.2mm guide wire.Without a valid part and lot number, the udi is not available.Without a part number for the reported guide wire, it cannot be confirmed if the wire was an implantable device that was implanted during the original procedure in (b)(6) 2015 or an instrument that was inadvertently left in the patient.Without this information, the applicability of implant/explant dates is unknown.Original procedure: (b)(6) 2015.Revision procedure: (b)(6) 2016.The complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).Unknown, as specific part and lot numbers for the complainant guide wire were not provided.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

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that a patient was returning to the operating room for revision on (b)(6) 2016 due to non-union.During the pre-operative x-ray review (images captured on unknown date[s]), it was noted that a 3.2mm guide wire had lodged in the head of the treated area.On (b)(6) 2015, the patient was originally fixated with a trochanteric fixation nail advanced (tfna) construct.Presence of the guide wire in the head was not noted until just before the revision procedure.No additional information pertaining to this event was provided.Concomitant device(s) reported: tfna nail (part: 04.037.063s / lot: 7754914 / quantity: 1).This report will address the issue with the guide wire only.The reason for revision has been captured in and reported under linked complaint (b)(4).This report is for one (1) unknown 3.2mm guide wire.This report is 1 of 1 for (b)(4).

• Type of Device: WIRE, SURGICAL
• 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: 5789984
• MDR Text Key: 49401385
• Report Number: 2520274-2016-13459
• Device Sequence Number: 1
• Product Code: LRN
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/28/2016

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?: Yes
• Initial Date Manufacturer Received: 06/28/2016
• Initial Date FDA Received: 07/13/2016
• 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
• Treatment: 04.037.063S: 10MM/130 DEG TI CANN TFNA STERILE
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR