MAUDE Adverse Event Report: SYNTHES BETTLACH 11MM UNIVERSAL FEMORAL NAIL 400MM; NAIL, FIXATION, BONE

Catalog Number 274.130

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Pain (1994); Discomfort (2330); Limited Mobility Of The Implanted Joint (2671)

Event Type  Injury  

Manufacturer Narrative

(b)(6).Although a revision procedure was performed, the exact date is unknown.(b)(6).Subject device has been received; no conclusions could be drawn as the device is entering the complaint system.Device history record review: manufacturing location: (b)(4) - manufacturing date: january 9, 2015.No non-conformance reports 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.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 underwent a revision procedure on an unknown date due to nail breakage.The patient was originally treated on (b)(6) 2016 with the implantation of a universal femoral nail and locking bolts.During a follow up appointment in (b)(6) 2016, the patient reported experiencing pain, discomfort, and limited weight-bearing.Subsequent x-ray images identified breakage of the nail.The patient was returned to the operating room where the broken nail was replaced with an unknown construct.Concomitant device(s) reported: 4.9mm locking bolt 40mm (part: 259.400 / lot: 9286278 / quantity: 1), 4.9mm locking bolt 44mm (part: 259.440 / lot: 9330101 / quantity: 1), and 4.9mm locking bolt 48mm (part: 259.480 / lot: 9403524 / quantity: 1).This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Additional narrative: a manufacturing investigation action was conducted /performed.The report indicates that: the product was returned in a packaging different from the original packaging.The laser marking was readable.The nail was broken at the second drill hole from the point of view of the nail tip.Traces of use were visible.Date sample received at investigation site oct 5, 2016.The "investigation summary" is a translated conclusion.A dhr review for the article 274.130 was performed for the affected lot (9317442), no abnormalities or deviations were detected, which could lead to the complaint failure.The diameters, 10.6, relevant for the function of the product were measured, and fulfill the specification.The raw material certificate was checked and it was found that the used raw material fulfilled the specifications.Based on this the complaint is rated as confirmed and not valid from the point of view of the manufacturing site.No manufacturing related issues was identified and it is not confirmed because of this issue, therefore review to the specific prm and prm line is not applicable.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

Update 5.Oct.2016: breakage occurred in a screw hole.

• Brand Name: 11MM UNIVERSAL FEMORAL NAIL 400MM
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5993247
• MDR Text Key: 56171743
• Report Number: 9612488-2016-10406
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K914371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 09/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 274.130
• Device Lot Number: 9317442
• Other Device ID Number: (01)07611819011496(10)9317442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 259.400: 4.9MM LOCKING BOLT 40MM; 259.440: 4.9MM LOCKING BOLT 44MM; 259.480: 4.9MM LOCKING BOLT 48MM
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR