MAUDE Adverse Event Report: SYNTHES BETTLACH IMPACTOR F/PFNA BLADE

Catalog Number 03.010.410

Device Problem Fitting Problem (2183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/12/2016

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: patient gender is unknown.Device is an instrument and is not implanted or explanted.(b)(6).Device is not distributed in the united states, but is similar to a device marketed in the us.Product investigation summary: the complainant implant (part: 04.027.033s pfna blade) and instruments (part: 356.818 protect sleeve; part: 03.010.410 impactor) were received for investigation.The parts were received in an assembled state.For every part, a device history record (dhr) review was performed with no abnormalities or deviations detected amongst any of the devices.The articles were manufactured in november, 2015 (blade), june, 2010 (sleeve), and december, 2012 (impactor).No non-conformance reports were identified during production.During the investigation, the parts were successfully disassembled.A functional test was performed on all parts and each device successfully passed.The impactor and the sleeve are in used, but otherwise good condition.The blade is damaged at the tip, which is a possible reason for the difficult insertion of the nail.Based on the provided information, it is impossible to determine the exact cause for this occurrence.It is likely that an application error during the procedure took place.To prevent such problems, it is necessary to operate according to the technique guide.No product fault could be detected.Device history record review: manufacturing site: (b)(4) - manufacturing date: december 10, 2012.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 proximal femoral nail antirotation (pfna) nailing procedure on (b)(6) 2016.As the pfna blade was being inserted, the handle would not turn, preventing the blade from locking into place.It was further noted that the handle would not turn in either direction; additionally, the insertion handle was stuck in blade inside the patient.The entire sleeve assembly, including the blade and insertion handle, was removed from the patient using a bristow as leverage.The blade was then replaced with an alternative 85mm blade.The new device was inserted using the extraction device.As a result of the intra-operative issue, a shorter implant was used than what was desired and the patient did not receive the optimal length blade.The procedure was completed with a fifteen (15) minute delay.At this time, the patient is noted to be ambulatory without aid.Update: an additional instrument (impactor) was received by the manufacturer in relation to this complaint.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Investigation results submitted in medwatch follow-up #1.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Update: an additional instrument (protection sleeve) was received by the manufacturer in relation to this complaint.This report is 2 of 3 for (b)(4).

• Brand Name: IMPACTOR F/PFNA BLADE
• Type of Device: IMPACTOR
• 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: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5759814
• MDR Text Key: 48506459
• Report Number: 9612488-2016-10278
• Device Sequence Number: 1
• Product Code: HWA
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 05/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.410
• Device Lot Number: 8165189
• Other Device ID Number: (01)07611819349476(10)8165189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/22/2016
• Initial Date FDA Received: 06/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2012
• 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 Age: 92 YR
• Patient Weight: 55