MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. BONE SCREW SELF-TAPPING 6.5 MM DIA. 35 MM LENGTH; PROSTHESIS HIP

Model Number N/A

Device Problem Fitting Problem (2183)

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

Event Date 11/14/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item# 00-8757-000-02 screw hole plug - three pack lot# 63835908.Foreign source: (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.

Event Description

It was reported that screw went through the hole in the acetabular shell but did not catch.The screw and cup were removed and the cup was reinserted.Additional information requested; however, none was available.

Manufacturer Narrative

It was identified an internal software error produced and submitted an invalid device product code in the previous submissions related to this reporting.The device product code has been updated with no further changes.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 information available.

Event Description

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

Manufacturer Narrative

(b)(4).Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the device identified damage to the head as well as witness marks below the head on the screw shaft, above the threads, in the form of gouges.The screw head exhibited gouging, deformation of the hex, as well as shearing of the outer edge.The shear marks on the outer edge of the head are prominent on one side of the screw, indicating angled contact with the shell.Subsequently, the gouges on the screw shaft are more prominent on the same side as the shearing on the head.Both markings are indicative of an angled approach of the screw through the shell.Foreign debris was present on the surface of the screw and inside the hex area of the screw.Dimensional analysis was not possible due to the severity of damage to the screw head.Device history record (dhr) was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to use error.Evaluation of the returned screw identified witness marks on both the head and screw shaft that were indicative of an angled approach of the screw through the acetabular shell.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: BONE SCREW SELF-TAPPING 6.5 MM DIA. 35 MM LENGTH
• Type of Device: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 8134224
• MDR Text Key: 129374949
• Report Number: 0002648920-2018-00840
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• PMA/PMN Number: K934765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00625006535
• Device Lot Number: 64076421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention