MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. BONE SCREW SELF-TAPPING 6.5 MM DIA. 30 MM LENGTH; PROSTHESIS, HIP

Model Number N/A

Device Problems Fracture (1260); Insufficient Information (3190)

Patient Problems Foreign Body In Patient (2687); No Information (3190)

Event Date 01/06/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.

Event Description

It was reported that during fixation of the acetabular screw the top part of the screw was broken, as fixation was secure and screw could not be retrieved it was left in the acetabular cup and another screw inserted.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

This follow-up report is being submitted to relay additional information.D4: udi#: (b)(4).The event was confirmed with product received.Visual evaluation identified that the threaded portion of the screw had fractured off, and the fractured part was not returned.Damage was observed on the shank below the spherical radius.Sem analysis of the fracture surface revealed suspected crack initiation and exit areas, and indications of a torsional overload fracture.Sheared ductile overload dimples were identified throughout the fracture surface.No further evaluation could be performed with the returned device.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.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. 30 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: 9602327
• MDR Text Key: 175417602
• Report Number: 0002648920-2020-00033
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K934765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 05/19/2020

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 Model Number: N/A
• Device Catalogue Number: 00625006530
• Device Lot Number: 63259437
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/10/2020
• Initial Date FDA Received: 01/17/2020
• Supplement Dates Manufacturer Received: 05/15/2020
• Supplement Dates FDA Received: 05/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Weight: 71