MAUDE Adverse Event Report: SYNTHES BETTLACH PFNA-II BLADE L95 TAN; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 04.027.054S

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

Patient Problems Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Date 11/30/2016

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(4).Pma# 510k#unknown: device is not distributed in the united states, but is similar to device marketed in the usa.Device broke intra-operatively and was not implanted / explanted.Date returned to manufacturer.(b)(6).Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.(b)(4).Device history records review was conducted.The report indicates that: dhr review for: part 04.027.054s / 9558774, manufacturing location: (b)(4), manufacturing date: 13 july 2015, expiry date: 01 july 2025.No ncr's were generated during production that would contribute to the complaint condition.The review of the device history record shows that there were no issues during the manufacture of the product that would contribute to the complaint condition.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 on an event in (b)(6) as follows: it was reported that during proximal femoral nail antirotation (pfna) surgery the blade broke.The event happened during an initial surgery.The surgeon tried to retrieve the broken off pieces but failed.Finally the surgeon changed the blade and took a new one to complete the procedure.The broken off piece is still in the patient.Patient condition is stable.There was no patient harm and the surgery was not prolonged.The surgery was successfully completed.This complaint involves 1 part.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

A product investigation was performed.The device shows abraded color striations on both flanks of the body sleeve.One of the four helix blades is heavily damaged.There is a missing gap of several square millimeters which broke off during surgery as per complaint description.The broken off portion is not available for investigation.The fracture surface is strongly abraded indicating that the damage occurred because the blade hit another metallic subject with high expenditure of energy.Beside the described damage the blade is fully functional as it passed the performed functional test.The device passed the blade bore of a test pfna-ii nail and could be locked and unlocked as foreseen.The review of the manufacturing documents showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Lot 9558774 was manufactured in july 2015 in a quantity of (b)(4) parts and we are not aware of any quality issues associated with this article and lot number.The surgical technique describes the complex alignment procedures of proximal femoral nail antirotation surgeries.We are not able to determine the root cause for this complaint but we conclude that the cause of failure is not due to any manufacturing non-conformances.No manufacturing related issue was identified and/or confirmed.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: PFNA-II BLADE L95 TAN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6199703
• MDR Text Key: 63133134
• Report Number: 9612488-2016-10523
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.027.054S
• Device Lot Number: 9558774
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 63