MAUDE Adverse Event Report: SYNTHES GMBH 2.0MM CANNULATED DRILL BIT/QC 150MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT

Catalog Number 310.221

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/05/2021

Event Type  malfunction  

Manufacturer Narrative

Additional product code: gfa, hwe, gff complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021 the tip of the drill was broke.The tip did not remain inside the patient.This report is for one (1) 2.0mm cannulated drill bit/qc 150mm.This is report 1 of 1 for complaint (b)(4).

• Brand Name: 2.0MM CANNULATED DRILL BIT/QC 150MM
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11744769
• MDR Text Key: 251477760
• Report Number: 8030965-2021-03410
• Device Sequence Number: 1
• Product Code: HSZ
• UDI-Device Identifier: 07611819086074
• UDI-Public: (01)07611819086074
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 310.221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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