MAUDE Adverse Event Report: SYNTHES BETTLACH PFNA BLADE PERF L110 TAN; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.027.037S

Device Problem Failure to Align (2522)

Patient Problems Sedation (2368); No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 08/01/2016

Event Type  Injury  

Manufacturer Narrative

Patient identifier and weight are unknown.The reported surgical delay and change in surgical plan have been captured in and reported under the medwatch for the pfna nail.The report for the pfna blade has been assessed as a reportable malfunction only for the failure to align.Additional product codes for this report include hwc.(b)(4).Due to the intra-operative misalignment issues, the device was not implanted.The complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).Device is not distributed in the united states, but is similar to a device marketed in the us.Investigation could not be completed and no conclusion could be drawn as no device was returned.Device history record review: manufacturing location: (b)(4) - manufacturing date: april 22, 2016 - expiry date: april 1, 2026.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 europe reports an event in (b)(6) as follows: it was reported that a patient underwent a proximal femoral nail antirotation (pfna) procedure on august 1, 2016.During insertion, the pfna blade would not go through the nail.As a result, the pfna construct was removed and the patient implanted with a competitor's gamma nail.The procedure was completed with a seventy-five (75) minute delay.Post-operatively, the patient was noted to be fine.No additional information is available.Concomitant device(s) reported: aiming arm (part/lot: unknown / quantity: 1), insertion handle (part/lot: unknown / quantity: 1), and protection sleeve (part: 356.818 / lot: 8883954 / quantity: 1).This report is 2 of 2 for (b)(4).

Manufacturer Narrative

Subject device has been received; no conclusions could be drawn as the device is entering the complaint system.The protection sleeve is no longer considered concomitant.It has been added as a separate part form on this complaint.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: the reported blade was returned stuck inside of the protection sleeve.As such, the sleeve has been added as a complained device on this complaint.This report is 2 of 3 for (b)(4).

Manufacturer Narrative

Si selected in error on the initial medwatch.This report represents a malfunction.Device used for treatement, 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.Based on the results of the product investigation, this event was determined to be an adverse event that required intervention and a product problem.(b)(4).Clarification of product investigation: a manufacturing investigation was performed for the complained device (pfna blade perf l110 tan, part number 04.027.037s, lot number 9919964).The subject device was received in a badly damaged condition.The pfna blade was received jammed in the protection sleeve and could not be disassembled.Furthermore, the tip of the pfna blade is heavily damaged.As previously reported, the review of the device history record revealed no findings that would have contributed to the complained event.Although the complaint condition is confirmed, no definitive root cause was able to be determined.However, based on the damages incurred it is probable that the protection sleeve was not aligned correctly to the pfna nail hole.Subsequently applied excessive stress during procedure caused the jamming of the parts.Evaluation codes were corrected from previous supplemental report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

An investigation summary was performed.The investigation of the complaint articles has shown that: visual inspection: jammed in protection sleeve, tip of blade is heavily damaged dhr no findings dimension: could not be verified due to the damage incurred according to the specifications.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements.No manufacturing related issues that would have contributed to this complaint were found.The review of the provided x-ray did also not allow for a conclusive statement regarding a possible failure reason.No definitive root cause was able to be determined.However, based on the damages incurred it is likely that the protection sleeve was not aligned correctly to the pfna nail hole.The type and extent of damage observed on the returned parts is, however, indicative of incorrect use; subsequently, excessive stress caused the jamming of the parts.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.

• Brand Name: PFNA BLADE PERF L110 TAN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• 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: 5853097
• MDR Text Key: 51353974
• Report Number: 9612488-2016-10328
• 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,Followup,Followup,Followup
• Report Date: 08/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.027.037S
• Device Lot Number: 9919964
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR