MAUDE Adverse Event Report: SYNTHES GMBH EXTRACTION SCREW FOR PFNA BLADE; EXTRACTOR

Catalog Number 03.010.411

Device Problems Mechanical Problem (1384); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/08/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).Additional narrative: additional product code : hxx investigation summary : investigation selection.Investigation site: (b)(4).Selected flow(s): 3.Damaged: visual | examples: deformed/bent/cracked/broken visual inspection: upon visual inspection of the complaint device it can be seen that the instrument is broken at the threaded tip end, this thus confirming the complaint description, the broken tip prevents the instrument from function.Furthermore, the remaining thread flank shows signs of deformation.Otherwise, the instrument is in a good condition with just a few signs of use.Dimensional inspection: the complaint relevant dimensions cannot be checked for dimensional accuracy, because of the damage.Furthermore, the investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the device, therefore no dimensional inspection is needed.Document/specification review: drawings and revisions are in accordance to dhr of production lot.All relevant features are defined on the used drawing revisions of dhr of production lot.Furthermore, all parts went through final inspection, thread m7x1 inspected 100%, before they had left the production.Material 1.4123 is identified, and hardness is documented according to the specification.Also, the inner diameter 3.4 +/-0.05mm went through final inspection and is documented according to the specification.Summary: the complaint is confirmed, as the thread at the tip is damaged as reported.The review of the production history revealed that this item was manufactured according to the specifications.No manufacturing related issues that would have contributed to this complaint condition were found.Moreover, a review of our complaints database shows, that there are no other complaints for this issue from this article and lot number.There is no particularize information what's happened to this article by customer, unfortunately we are not able to determine the exact reason for this occurrence, but we assume that during the operation an application error may have taken place or/and that inadequate connection between the extracts of/pfna blade and the pfna blade led to this damage.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot part # 03.010.411.Lot # l019754.Manufacturing site: (b)(4).Release to warehouse date: june 22, 2016.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021 the patient underwent for an unknown surgery.During the surgery when the surgeon tried to use the instrument but failed.The surgery was completed successfully without delay reported.There were no patient consequences are reported.This complaint involves one (1) device.This report is for (1) extraction screw for pfna blade this report is 1 of 1 pc (b)(4).

• Brand Name: EXTRACTION SCREW FOR PFNA BLADE
• Type of Device: EXTRACTOR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11557011
• MDR Text Key: 245151603
• Report Number: 8030965-2021-02229
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 07611819349483
• UDI-Public: (01)07611819349483
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: EXEMPT
• 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: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.411
• Device Lot Number: L019754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1