MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. ZIMMER SELF-TAPPING BONE SCREW

Catalog Number 00625006525

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/19/2016

Event Type  Injury  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It was reported that while tightening the acetabular bone screw, the head of the screw sheared off, leaving broken screw threads in the pelvis of the patient.

Manufacturer Narrative

This follow up report is being filed to relay additional information.(b)(4).Device was evaluated and the reported event was confirmed through visual examination of the returned remainder of the screw.A hex head of a fractured bone screw was returned for evaluation.Damage is seen on the shank head radius that indicates it was driven through the shell screw hole.Damage is too severe for dimensional analysis.Equiaxed dimples were observed over the bulk of the fracture surface.Equiaxed dimples are consistent with a ductile tensile overload fracture.Device history records were reviewed with no issues noted that would cause or contribute to the reported event.Review of the complaint history found no other reports of this nature for the reported part/lot number combination, and it was determined that no further action is required as no trends were identified.The most probable cause was found to be consistent with a ductile tensile overload fracture.Findings were relayed to the complainant.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: ZIMMER SELF-TAPPING BONE SCREW
• Type of Device: BONE SCREW
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582-0708 ; 5745273773
• MDR Report Key: 5886087
• MDR Text Key: 52426691
• Report Number: 0002648920-2016-00987
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PK934765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00625006525
• Device Lot Number: 63341509
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/21/2016
• Initial Date FDA Received: 08/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other