MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC K-WIRE ATTACHMENT FOR PEN DRIVE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number 05.001.037

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(6).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.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 from (b)(6) that the k-wire attachment device did not function and parts of the device were coming off.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in a surgical procedure or if a spare device was available.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

Device was used for treatment, not diagnosis.This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the bearing of the attachment device seized, jammed, and was moving heavily.It was noted that the attachment was rough running.It was further determined that the device failed pretest for function test, check of free moving, check clamping rang on tool coupling, and check sleeve for spring tick ¿pass¿, if hexagon end.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to wear from normal use and servicing.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: K-WIRE ATTACHMENT FOR PEN DRIVE
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES PRODUKTIONS GMBH; hauptstrasse 24; waldenburg 4437 ; SZ 4437
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7473532
• MDR Text Key: 106978408
• Report Number: 8030965-2018-53449
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 7611819167872
• UDI-Public: (01)7611819167872
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K043310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.037
• Device Lot Number: 7697649
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2012
• 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