MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 SCREW 6.5MM X 15MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/24/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog# 010000996 g7 screw 6.5mm x15mm lot# 6596540.Catalog# 51-106160 tprlc 133 mp type1 pps so 16.0 lot# 6594554.Catalog# 51-108050 tprlc 133 mp t1 pps so 5x95mm lot# 6589364.Catalog# 51-145120 tprlc xr mp t1 pps 12x109mm lot# 6561974.Report source: foreign: (b)(6).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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-04636, 0001825034-2019-04637, 0001825034-2019-04640, 0001825034-2019-04648.

Event Description

It was reported that debris in the sterile packaging was observed during incoming inspection.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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

Manufacturer Narrative

Udi#: (b)(4).The event was confirmed with product received.Upon visual inspection, foreign debris was found inside the returned devices.Dhr was reviewed and no discrepancies relevant to the reported event were found.The likely condition of the devices with foreign debris (not related to packaging material) when they left zimmer biomet is non-conforming to specification.The root cause of the reported event is the operator not following the work instructions provided.A corrective action for the foreign debris was opened to address the issue of complaints for debris in sterile packaging.The corrective action closed successfully, following the manufacture of the lot in the reported 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.

• Brand Name: G7 SCREW 6.5MM X 15MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9197830
• MDR Text Key: 199909591
• Report Number: 0001825034-2019-04635
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 02/21/2020

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: 010000996
• Device Lot Number: 6596540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/24/2019
• Initial Date FDA Received: 10/16/2019
• Supplement Dates Manufacturer Received: 02/20/2020
• Supplement Dates FDA Received: 02/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1