MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL AUGMENT SCREWDRIVER 3.5 MM HEX; INSTRUMENT, KNEE

Model Number N/A

Device Problems Fracture (1260); Separation Failure (2547)

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

Event Date 10/13/2021

Event Type  malfunction  

Event Description

When trying to unscrew the set screw on the distal rod the screwdriver broke.The screw had wedged it self and was and is impossible to unscrew.Instrument needs to be replaced.No harm came to the patient.

Manufacturer Narrative

(b)(4).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.Associated products : item#: 00599707100; distal telescoping rod; lot#: 62145792.Report source: foreign : (b)(6).

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record for the screwdriver identified no deviations or anomalies during manufacturing.The reported event is not related to a combination of products; therefore a compatibility review is not applicable.Medical records were not provided.The complaint cannot be confirmed.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after the investigation of this event.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: FEMORAL AUGMENT SCREWDRIVER 3.5 MM HEX
• Type of Device: INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12771033
• MDR Text Key: 280466739
• Report Number: 0001822565-2021-03208
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/22/2022

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00598708900
• Device Lot Number: 78512300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/13/2021
• Initial Date FDA Received: 11/08/2021
• Supplement Dates Manufacturer Received: 03/08/2022
• Supplement Dates FDA Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2001
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10.