MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVS 2.7MM DIA DRL; INSTRUMENT EXTREMITY

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/26/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Udi: n/a.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during comprehensive reverse shoulder arthroplasty, following the rilling for the 3.5 mm hex fixed locking screw, the distal cutting threaded end of the drill bit was found broke off.X-rays showed the tip was found in the patient medial to the respective screw.No additional information available at this time.

Manufacturer Narrative

(b)(4).Updated: a1, a4, b4, b5, b6, b7, e1, g4, h1, h2, h10.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was further reported that during an initial right comprehensive reverse shoulder arthroplasty approximately 3 months ago, following drilling for the 3.5 mm hex fixed locking screw, the distal cutting threaded end of the drill bit was found broke off.X-rays showed the tip was found in the patient medial to the respective screw.Reoperation for removal is not planned at this time and the pt appears to be recovering as expected without complications.Attempts have been made and there is no additional information available at this time.

Manufacturer Narrative

(b)(4).If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).Updated: b4, b5, g4, h1, h2, h3, h6, h10 reported event was confirmed as the returned product had the drill bit fractured.Medical records state the reoperation for removal of drill bit from the patient is not necessary.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: COMP RVS 2.7MM DIA DRL
• Type of Device: INSTRUMENT EXTREMITY
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10301579
• MDR Text Key: 200811975
• Report Number: 0001825034-2020-02862
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 405889
• Device Lot Number: 398920
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Weight: 80