MAUDE Adverse Event Report: SYNTHES BETTLACH 12MM UNIVERSAL FEMORAL NAIL 360MM; NAIL,FIXATION,BONE

Catalog Number 274.210

Device Problem Failure to Osseointegrate (1863)

Patient Problem Impaired Healing (2378)

Event Type  Injury  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that a femoral nail was removed because it wasn¿t consolidating the bone and two screws were broken.The damaged products were replaced.The patient status after the revision surgery was reported as normal.There was no reported delay in the surgery.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

The investigation could not be completed; no conclusion could be drawn, as no product was received.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Date of event: unknown.Implant date: unknown.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.

Manufacturer Narrative

A manufacturing evaluation was completed: the universal femoral nail (ufn) is broken and twisted.The investigation has shown that the nail is broken off as complained.Furthermore, the nail shows also badly deformation apart the two cracks.The measurable dimension of the nail were checked as far as possible and found to be in compliance with the technical drawings and ao/asif specification.The relevant dimension of the nail cannot be measured due to its broken off/damaged condition.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The examination of the raw-material testing certificates and the manufacturing papers showed no deviations regarding material analysis, strength and structural stability.The values were in compliance with ao/asif specification and with the international standard.No additional information available; therefore, no further evaluation can be conducted.Unfortunately we are not able to determine the exact cause which has led to the breakage.It is likely that inadequate handling may have led to the breaking.No product fault could be detected.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: 12MM UNIVERSAL FEMORAL NAIL 360MM
• Type of Device: NAIL,FIXATION,BONE
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH25 44; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH25 44; SZ CH2544
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3761626
• MDR Text Key: 4552669
• Report Number: 9612488-2014-10108
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK914371
• 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: 03/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 274.210
• Device Lot Number: 2383749
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2008
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention