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

Catalog Number 356.823

Device Problems Fitting Problem (2183); Mechanical Jam (2983)

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

Event Date 08/11/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient information is not available for reporting.The part number of the subject device was unknown until the receipt of the subject device by the manufacturer on sep 23, 2016.Once the part number was identified, a complaint history for the part could be reviewed and the complaint, initially determined to be non-reportable, was determined to be reportable based on a positive complaint history for similar event.Implant and explant: device is an instrument and is not implanted/explanted.The subject device is not expected to be returned to the synthes manufacturer for evaluation.Initial reporting facility phone number is (b)(6).Pma 510(k): device is not distributed in the united states, but is similar to device marketed in the usa.A device history record review was performed for the subject device lot.Manufacturing location: synthes (b)(4).Product manufacture date: may 21, 2007.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.No manufacturing-related issues were identified.The investigation could not be completed; no conclusion could be drawn, as no product was received.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) reported an event in (b)(6) as follows: it was reported that during surgery the surgeon assembled the proximal femoral nail blade (pfna blade) onto the insertion handle.The surgeon impacted the blade into the femoral head and during his attempt to lock it the blade became stuck to the insertion handle.The surgeon had to remove the blade and use a different blade and insertion handle.Multiple unsuccessful attempts were made to disengage the blade from the insertion handle.The surgery was successfully completed with another same type insertion handle from another set.There was a surgical delay of 15-20 minutes due to the reported event; however, there was no harm to the patient.This report is 2 of 2 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: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6018757
• MDR Text Key: 57087736
• Report Number: 9612488-2016-10415
• Device Sequence Number: 1
• Product Code: HWA
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 08/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 356.823
• Device Lot Number: 2268332
• Other Device ID Number: (01)07611819291317(10)2268332
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2007
• 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