MAUDE Adverse Event Report: SYNTHES USA; NAIL, FIXATION, BONE

Device Problem Component Missing (2306)

Patient Problems Sedation (2368); Blood Loss (2597); No Code Available (3191)

Event Date 03/12/2015

Event Type  Injury  

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that an adolescent lateral entry femoral nail (alfn) instrument kit was missing the base of an alfn nail, which could not be used alone.The discovery of the missing part was made on (b)(6) 2015 while the patient was already under anesthesia.The (b)(6) patient was woken up and re-scheduled for surgery the following day.An ancillary lfn was borrowed from another local hospital (that assisted with the ancillary nail expert tibial).The patient was again anesthetized on (b)(6) 2015 -- the operation was considered successful, but the patient experienced severe bleeding problems.The surgeon admitted resuscitation.This report is for one (1) unknown alfn instrument kit.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Patient identifier, gender, and weight are unknown.Discovery of the missing part occurred on (b)(6) 2015.The surgical events (i.E.Bleeding) occurred during the procedure on (b)(6) 2015.This report is for one (1) unknown alfn instrument kit.Device is an instrument and is not implanted or explanted.Per facility, complainant instrument kit is not available for return.(b)(4).A 510k number is not applicable to an entire instrument set.Without the exact part and lot number of the missing piece, a 510k number cannot be determined.Investigation could not be completed and no conclusion could be drawn as no device was returned and no lot number or part number was provided.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.

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 that specifically the base of the nail alfn was missing; only the complement alfn was delivered.

• 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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4631085
• MDR Text Key: 5758678
• Report Number: 2520274-2015-12106
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 03/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2015
• 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
• Patient Age: 12 YR