MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMPRESS TRANSVERSE PIN TI 40M M; PROSTHESIS, HIP

Model Number N/A

Device Problem Component Missing (2306)

Patient Problem No Code Available (3191)

Event Date 01/23/2017

Event Type  Injury  

Manufacturer Narrative

Medical product- compress 5cm taper adapter catalog#178711 lot# ni, compress oss locking cap and screw catalog# 178710 lot# ni, compress ha anti-rotation spindle small 38mm 800lbf porous coat catalog# 178355 lot# ni, compress segmental anchor plug 14mm catalog# 178404 lot# ni, compress finn nut catalog# 178512 lot# ni, compress finn transverse pin size 36mm catalog# 178528 lot# ni, compress transverse pin ti 40m m catalog# 178529 lot# ni, compress finn transverse pin size 48mm catalog# 178531 lot# ni, compress short anchor plug 10mm catalog# 178552 lot# ni, cps short anchor plug 14mm catalog# 178556 lot# ni.This report is number 5 of 10 mdrs filed for the same patient (reference 0001825034 - 2017 - 00779 , 0001825034 - 2017 - 00782, 0001825034 - 2017 - 00791, 0001825034 - 2017 - 00794, 0001825034 - 2017 - 00795, 0001825034 - 2017 - 00797, 0001825034 - 2017 - 00802, 0001825034 - 2017 - 00803, 0001825034 - 2017 - 00804, 0001825034 - 2017 - 00868).

Event Description

It was reported that items were missing in the implant sets and the case had to be cancelled.The patient had an epidural in when it was noticed that the components were missing.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Dhr review was unable to be performed as the lot number of the device involved in the event is unknown.A process review revealed that the appropriate contents were included in the kit and procedure was followed by the manufacturer in communicating said contents to the distributorship; however, the kit documentation completed by the distributorship on the outside of the container did not indicate accurate contents.Review of complaint history determined that no further action is required as no trends were identified.Investigation results concluded that the reported event was due to a labeling problem by the distributorship.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: COMPRESS TRANSVERSE PIN TI 40M M
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6350097
• MDR Text Key: 68047049
• Report Number: 0001825034-2017-00795
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK043547
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2017
• 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: 178529
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 26 YR