MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH HELICAL BLADE/SCREW EXTRACTOR; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 03.037.030

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Reporter is a j&j employee.Investigation summary: investigation site: (b)(4), selected flow: device interaction/functional.Visual inspection: the extraction instrument and the tfna screw were received in assembled condition.The visible part of the extraction instrument is in a good condition with no visible damages.Functional testing: the tfna screw and the extraction instrument were returned in assembled condition.During the performed function test it was possible to disassemble the devices with a wrench as described in the surgical technique with moderate force.The complained seizing can not be confirmed.The thread was full with dried red residues which made an additional decontamination possible before the function test was continued.After the decontamination it was possible to assemble and disassemble the screw and the instrument as required.Document/specification review: the tfna surgical technique ((b)(4)) was reviewed.The removal of the tfna screw from the extraction instrument is described on page 73 with following statement: to remove the helical blade or screw from the extraction instrument rotate clockwise.Investigation conclusion: the complained seizing could not be confirmed during the performed function test.It was possible to remove the screw as required, therefore is this complaint rated as unconfirmed.Based on the provided information the exact cause of this occurrence could not be defined.It may be that the fact that the devices have a left-handed thread and that therefore clockwise turning is needed for disassembling was not considered.Also the dried residues may have played a certain role 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 number: 03.037.030, lot number: l203844, manufacturing site: (b)(4), release to warehouse date: (b)(4) 2016.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's 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 on (b)(6) 2020 that on an unknown date, the tfna fenestrated screw seized onto the helical blade/screw extractor.The issue was discovered during loan kit inspection.There is no further information available.This report is for one (1) helical blade/screw extractor.This is report 1 of 2 for (b)(4).

• Brand Name: HELICAL BLADE/SCREW EXTRACTOR
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES HAEGENDORF GMBH-CN; im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10601015
• MDR Text Key: 209005118
• Report Number: 8030965-2020-07506
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819642560
• UDI-Public: (01)07611819642560
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K131548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.037.030
• Device Lot Number: L203844
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2016
• 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
• Treatment: TFNA SCR PERF L100 TAN