MAUDE Adverse Event Report: SYNTHES OBERDORF QC F/DHS/DCS TRIPLE REAMERS F/TRS; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number 05.001.213

Device Problems Difficult to Insert (1316); Device Operates Differently Than Expected (2913)

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

Event Date 10/17/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Please note that the reporter's full name, phone number, and email address were not provided.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 the (b)(6) that during an unspecified surgical procedure it was observed that the wire devices could not be held in the jaws of the quick coupling device.It was not reported if there was delay in the procedure due to the event, or if a spare device was available for use.There was patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

Manufacturer Narrative

The device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.The device was evaluated and it was determined that coupling tool side of the device seized, jammed, and was moving heavily.It was noted that there was a coupling tool side defect.It was further determined that the device failed pretest for check the untrue running, check of noticeable noise, and check the tool coupling.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to premature wear.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: QC F/DHS/DCS TRIPLE REAMERS F/TRS
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• Manufacturer (Section D): SYNTHES OBERDORF; eimattstrasse 3; oberdorf CH443 6; SZ CH4436
• Manufacturer (Section G): SYNTHES OBERDORF; eimattstrasse 3; oberdorf CH443 6; SZ CH4436
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7014656
• MDR Text Key: 91899336
• Report Number: 8030965-2017-16048
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 10/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1