MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. CORTICAL BONE SCREW SELF-TAPPING HEX HEAD 4.5 MM DIAMETER 120 MM LENGTH; PLATE, FIXATION

Catalog Number 00234712320

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Patient Involvement (2645)

Event Date 03/04/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4) report source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2019-00169.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.Product not returned.

Event Description

It was reported that the length of the screws are not consistent with the labeling.There was no patient involvement.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Visual inspection and dimensional analysis of the returned products confirmed the screws are shorter than the actual length confirming the complaint.Device history record was reviewed and no discrepancies relevant to the reported event were found.The operator is considered a contributory factor for the reported event as the operators failed to detect the non-conformity.However, a definitive cause that triggered the smaller screw non-conformance during manufacturing could not be determined.The complaint is being reviewed through the capa process to determine what further actions are necessary.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: CORTICAL BONE SCREW SELF-TAPPING HEX HEAD 4.5 MM DIAMETER 120 MM LENGTH
• Type of Device: PLATE, FIXATION
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 8403250
• MDR Text Key: 138213925
• Report Number: 0002648920-2019-00170
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K142579
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/24/2019

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 Catalogue Number: 00234712320
• Device Lot Number: 61347128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/05/2019
• Initial Date FDA Received: 03/08/2019
• Supplement Dates Manufacturer Received: 05/22/2019
• Supplement Dates FDA Received: 05/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1