MAUDE Adverse Event Report: ACUMED LLC 2.8MM TAP DRILL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number HR-D105

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/30/2017

Event Type  malfunction  

Event Description

While drilling in the humerus bone of a patient, the drill tip broke off.It was left implanted.

• Brand Name: 2.8MM TAP DRILL
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ACUMED LLC; 5885 nw cornelius pass road; hillsboro OR 97124
• Manufacturer (Section G): ACUMED LLC; 5885 nw cornelius pass road; hillsboro OR 97124
• Manufacturer Contact: micki lehman ; 5885 nw cornelius pass road; hillsboro, OR 97124 ; 8886279957
• MDR Report Key: 7135002
• MDR Text Key: 95867440
• Report Number: 3025141-2017-00337
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: HR-D105
• Device Catalogue Number: HR-D105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/12/2017
• Initial Date FDA Received: 12/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 75 YR