MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 3.5 MM HEX HEAD SCREW; BONE, FIXATION, SCREW

Catalog Number 00590103533

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Multiple mdr's were filed in association with this reporting: 0001822565 - 2019 - 02701, 0001822565 - 2019 - 02702, 0001822565 - 2019 - 02703, 0001822565 - 2019 - 02704, 0001822565 - 2019 - 02705, 0001822565 - 2019 - 02706.Concomitant medical products: 00590103533 hex screw lot 61627212, (01)00889024201699, 00597909541 reamer lot 64192658, (01)00889024217522, 00597909541 reamer lot 64264651, (01)00889024217522, 00598004702 stemmed tibia lot 64020358, (01)00889024217614, 00598009000 stem extension lot 64062432, (01)00889024217669, 42512400412 art surface lot 63395715, (01)00889024237025.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported during the distribution process packaging damage with sterility barrier potentially compromised was identified.No patient or surgical involvement.No further information available at this time.

Manufacturer Narrative

It was determined this device did not cause or contribute to a reportable malfunction, serious injury, or adverse event.Please void this submission.

Event Description

It was determined this device did not cause or contribute to a reportable malfunction, serious injury, or adverse event.Please void this submission.

• Brand Name: 3.5 MM HEX HEAD SCREW
• Type of Device: BONE, FIXATION, SCREW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8743538
• MDR Text Key: 149503752
• Report Number: 0001822565-2019-02701
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 00590103533
• Device Lot Number: 61627212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1