MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH 2.0MM SPADE-POINT REDUCTION WIRE 400MM; APPLIANCE,FIXATION,NAIL

Catalog Number 292.410

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2017

Event Type  malfunction  

Manufacturer Narrative

No patient involvement was reported.Additional product code: lxt.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).Subject device has been received and is currently in the evaluation process.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

It was reported that during an inventory check before the surgery, it was found that the wire had been bent entirely.In addition, a piece of the plastic material had been attached to the tip of the wire.The complaint device was never used to the patient.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Manufacturing location: (b)(4).Manufacturing date: may 23, 2011.No non-conformance reports were generated during production.Review of the device history record (dhr) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.A product investigation was completed: upon visual inspection of the complaint device it can be seen that wire is slightly bent as reported, this thus confirming the complaint description.Furthermore we have received the part with an open packaging.Dhr review showed no issues.During investigation the diameter was measured with the micrometer; the measure result is within specification.As the packaging is already opened up, we unfortunately aren¿t able to determine the exact reason for this reported problem.Furthermore as the packaging was open we are not able to determine where the piece of plastic is coming from.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: 2.0MM SPADE-POINT REDUCTION WIRE 400MM
• Type of Device: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): OBERDORF : SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7080275
• MDR Text Key: 93862281
• Report Number: 8030965-2017-50266
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 07611819069459
• UDI-Public: (01)07611819069459(10)3810196
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K161417
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 292.410
• Device Lot Number: 3810196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2011
• 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