MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 2MM DBALL,ST,S; DRILLS, BURRS, TREPHINES AND ACCESSORIES (SIMPLE, POWERED)

Catalog Number S-2SD-G1

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/23/2018

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.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 before surgery and before use on the patient, it was observed that the tip on the cutter device was bent.It was reported that there was no delay in the planned surgical procedure as an unspecified spare device was available for use.There was no patient involvement.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

Device was used for treatment, not diagnosis.The actual device was returned for evaluation.The cutter device was evaluated and the reported condition that the device was bent was confirmed.An assessment was performed and it was observed that the straightness and runout of the device were noted to be out of specification.It was further observed that there was medical debris on the cutter surface, predominantly on the distal end of the device.The assignable root cause was determined to be due to improper handling, which is user error/misuse/abuse.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: 2MM DBALL,ST,S
• Type of Device: DRILLS, BURRS, TREPHINES AND ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: rodney crain ; 4500 riverside drive; palm beach gardens, FL 33410 ; 5616271080
• MDR Report Key: 7288509
• MDR Text Key: 100775377
• Report Number: 1045834-2018-50331
• Device Sequence Number: 1
• Product Code: HBE
• UDI-Device Identifier: 845384012825
• UDI-Public: (01)845384012825(11)170613(10)L143122957
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K113476
• 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: 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: S-2SD-G1
• Device Lot Number: L143122957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1