MAUDE Adverse Event Report: SYNTHES (U.S.A.); INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED ACCESSORY/ATTACHMENT

Model Number 310.23

Device Problem Dull, Blunt (2407)

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

Event Date 09/18/2019

Event Type  malfunction  

Event Description

Md asked to use a 2.5mm drill bit from the synthes modular foot.After using drill bit once on patient, he looked closely at the drill bit tip and said "this drill bit is too dull." he requested a second 2.5mm drill bit which was available from the same set being used.

• Brand Name: NA
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED ACCESSORY/ATTACHMENT
• Manufacturer (Section D): SYNTHES (U.S.A.); 1210 ward ave; west chester PA 19380
• MDR Report Key: 9179165
• MDR Text Key: 161967729
• Report Number: 9179165
• Device Sequence Number: 1
• Product Code: HSZ
• UDI-Device Identifier: 10886982186263
• UDI-Public: (01)10886982186263
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 310.23
• Device Catalogue Number: 31023
• Device Lot Number: (10)H868285
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/27/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24820 DA
• Patient Weight: 100