MAUDE Adverse Event Report: SYNTHES TUTTLINGEN MILLING GUIDE 6MM

Catalog Number 03.820.115

Device Problem Difficult to Advance (2920)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/26/2014

Event Type  malfunction  

Event Description

It was reported that the surgeon had issues with the milling guide and the milling bit.Outside of the wound the milling guide appeared to work fine but once it was put in place, the inferior hole was milled with no problem, but the guide didn't move/sweep as it should for the superior hole.In an attempt to make the milling guide move, the milling bit broke.The surgeon used a new bit and flipped the milling guide to use the other end.The surgeon was able to remove the broken bit without any trouble.There was a delay in the procedure of 20 minutes as a result of the event.The surgeon was worried about the superior cut but he elected to proceed with the procedure.He was able to implant the device normally and it fit as it should.The procedure was completed successfully without any reported patient harm.This is 1 of 2 reports for complaint (b)(4).

Manufacturer Narrative

(b)(6).Device is an instrument and is not implanted/explanted.Subject device has been received and is currently in the evaluation process.Investigation is on going; no conclusion could be drawn.A review of the device history record revealed no complaint related anomalies.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Additional narrative: a product development evaluation was completed: a 6mm milling guide (03.820.115 lot a7qa48) was received intact and in good working condition.Minimal wear present is consistent with typical use.Drawings for the 6mm milling guide were reviewed: specifically those related to the pivot bearing guide, the pivot and the bearing.These drawings were found suitable to determine the intended device design, application and dimensional conformity.The milling guide was found to have met the drawings specifications.The product was received under the complaint condition does not function, will not advance.In the complaint description it was noted that during surgery, the milling guide didn¿t move/sweep as it should for the superior hole.In an attempt to make the milling guide sweep, the bit broke.The broken milling bit (03.820.167s) was discarded and could not be evaluated.The received milling guide shows no signs of a stuck or jammed pivot.Both are able to move freely across the full range of intended motion.It is possible that tissue, or other matter, became lodged inside the pivot mechanism during surgery and kept it from sweeping as designed.The decontamination procedure likely cleared out any material restoring functionality to the device.After reviewing the related product drawings, complaint history and risk analysis, the design is adequate for its intended use and did not contribute to this complaint condition.The complaint is confirmed.The complaint description describes a stuck or jammed pivot mechanism, however the received device functions fully.It is possible that during the procedure matter became lodged in the mechanism and caused it to jam.This material was likely removed by the decontamination procedure which restored functionality to the device.The device is determined to be suitable for its intended use.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: MILLING GUIDE 6MM
• Type of Device: GUIDE
• Manufacturer (Section D): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 7853 2; GM 78532
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 7853 2; GM 78532
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3687536
• MDR Text Key: 4297574
• Report Number: 9680938-2014-10005
• Device Sequence Number: 1
• Product Code: FZX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.820.115
• Device Lot Number: A7QA48
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2007
• 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
• Patient Age: 28 YR
• Patient Weight: 57