MAUDE Adverse Event Report: ZIMMER, TURPEAUX INDUSTRIAL PARK MULTIPOLAR BIPOLAR CUP LINER; KWY

Catalog Number 00500105028

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/06/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This report will be amended when our investigation is complete.

Event Description

It is reported a hair was seen in the liner after being opened in the sterile field.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

The device was returned for review and a hair was found sitting in the concave surface of the liner.The device history record was reviewed and the documentation indicated that all devices of that lot were manufactured and packaged to specifications.There were no deviations to the standard manufacturing process associated with this review.No additional complaints have been received against this manufacturing lot.Although foreign material could be introduced during the packaging process, zimmer takes several measures to prevent this from occurring.This device was packaged in a class 10,000 clean room, under a specially designed hooded packaging station that creates a class 1000 clean room environment that significantly reduces the presence of foreign contaminants.Personnel in the clean room are required to wear items such as hair nets, protective clothing and booties, to reduce the likelihood of foreign materials from being introduced during the packaging process.In addition, single-use, sterilized devices manufactured or distributed by zimmer are sterilized in accordance with fda regulations and iso standards to a sterility assurance level of 1.0 x 10-6 or better.Therefore, it is highly unlikely that the presence of the hair found in the packaging would have led to any infections or other bio-incompatibility if it had been used.With the information provided, the origin of the hair cannot be determined and thus a root cause cannot be stated.

• Brand Name: MULTIPOLAR BIPOLAR CUP LINER
• Type of Device: KWY
• Manufacturer (Section D): ZIMMER, TURPEAUX INDUSTRIAL PARK; rt. #1, km 123.4; bldg. #1; mercedita PR 00715
• Manufacturer (Section G): TURPEAUX INDUSTRIAL PARK; rt. #1, km 123.4; bldg. #1; mercedita PR 00715
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5134408
• MDR Text Key: 28061403
• Report Number: 2648920-2015-00364
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: Followup,Followup
• Report Date: 09/09/2015

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: 00500105028
• Device Lot Number: 62976240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/07/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/17/2015; 12/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1