MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS QUICK COUPLING FOR K-WIRES; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number 532.022VET

Device Problems Device Contamination with Chemical or Other Material (2944); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/07/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.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 a veterinary tibial plateau leveling osteotomy (tplo) surgery on a canine, it was discovered that the quick coupling device was making a grinding noise and a black residue came out of it.It was further reported that a small amount of the black residue fell into the patient but was flushed out vigorously.It was reported that there was a slight delay to the surgical procedure.The same device was used to complete the surgery successfully.There was no human patient involvement as the device was used in a veterinary procedure.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 report will be submitted accordingly.

Manufacturer Narrative

Additional narrative:the actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition was confirmed.A visual and functional assessment was performed on the device which found that the unit failed the smooth running check.During repair, it was observed that there was corrosion and unknown debris on the internal parts.It was determined that the bearing was damaged and had a rough rotation.It was further determined that the issues were consistent with improper cleaning.The assignable root cause was determined to be due to improper cleaning methods.If information is obtained that was not available, a follow-up medwatch will be filed as appropriate.

• Brand Name: QUICK COUPLING FOR K-WIRES
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• Manufacturer (Section D): DEPUY SYNTHES POWER TOOLS; hauptstrasse 24; waldenburg CH443 7; SZ CH4437
• Manufacturer (Section G): DEPUY SYNTHES POWER TOOLS; hauptstrasse 24; waldenburg CH443 7; SZ CH4437
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6903791
• MDR Text Key: 87769098
• Report Number: 8030965-2017-15172
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 532.022VET
• Device Lot Number: 100832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2013
• 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