MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 1.25MM THREADED GUIDE WIRE 150MM; WIRE, SURGICAL

Catalog Number 292.620

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/19/2019

Event Type  malfunction  

Manufacturer Narrative

Additional product code: hty.Occupation: initial reporter is a synthes sales consultant.Device evaluated by mfr, event problem and evaluation codes: the device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 (b)(4) reports an event as follows: it was reported that on (b)(6) 2019, during an open reduction and internal fixation (orif) surgery for the tibial diaphyseal and medial malleolus fracture was performed with an expert tibial nail (etn) and the guide wire.After inserting an etn successfully, the surgeon inserted an unknown 4.5mm cannulated cancellous screw into the medial malleolus.Then, inserted the guide wire to use additional unknown 4.0mm screws.The surgeon drilled near the side only and inserted the screw.When the guide wire was removed, it was noted that the tip of the wire was broken and the fragments remained in the bone.However, the surgeon decided to leave the fragments on an assumption that it can cause no harm since it is located in the bone.The fragments may be removed when the cannulated screw are extracted in the future.There was no surgical delay.Procedure and patient outcome were unknown.Concomitant devices reported: 4.5mm cannulated cancellous screw (part/lot unknown, quantity 1) and 4.0mm cannulated cancellous screw (part/lot unknown, quantity 1).This report is for a guide wire.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.State: osaka-fu device history revue part: 292.620 lot: 1l57870 manufacturing site: balsthal release to warehouse date: 18.Sep.2018 a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.The raw material certificate 1l04895 was reviewed and the used material was according to 316l specification.H3, h6: investigation summary investigation selection investigation site: cq zuchwil selected flow(s): 2.Device interaction/functional and 5.Broken visual inspection: upon visual inspection of the complaint device it can be seen that the tip is broken off, this thus confirming the complaint description.In addition the part shows some signs of use, but otherwise the article is in a good condition.Received part¿ on pi level.Functional test: because of the damage, a function test is not possible anymore.Document/specification review: drawings and revisions are in accordance to dhr of production lot 1l57870.All relevant features are defined on the used drawing revisions of dhr of production lot 1l57870.Dimensional inspection: during investigation the diameter was measured with the micrometre, the measure result is within accuracy.Furthermore the complaint relevant dimensions cannot be checked for dimensional accuracy, because of the damage.Material or hardness review: the raw material certificate was reviewed and the used material was according to specification.Summary: the complaint condition is confirmed as the part is broken.Production lot (1l57870) was manufactured in september 2018 according to the specification.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements with no non-conformities reported.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, however, it is likely that during the operation an application error may have taken place, and/or that excessive force during operation led to this damage.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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.

• Brand Name: 1.25MM THREADED GUIDE WIRE 150MM
• Type of Device: WIRE, SURGICAL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8429618
• MDR Text Key: 139107152
• Report Number: 8030965-2019-62035
• Device Sequence Number: 1
• Product Code: LRN
• UDI-Device Identifier: 07611819733121
• UDI-Public: (01)07611819733121
• Combination Product (y/n): N
• PMA/PMN Number: PRE-AMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/20/2019

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: 292.620
• Device Lot Number: 1L57870
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2019
• Initial Date Manufacturer Received: 02/20/2019
• Initial Date FDA Received: 03/18/2019
• Supplement Dates Manufacturer Received: 04/17/2019
• Supplement Dates FDA Received: 04/25/2019
• Patient Sequence Number: 1
• Patient Age: 17 YR