MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER 2.5 I M PLUG 14MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	09390114
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Not available.
Event or Problem Description
The customer reported that what appeared to be an eyelash was found inside the sterile package.
Additional Manufacturer Narrative
An event regarding foreign matter found in the packaging of an exeter plug was reported.The event was confirmed by photograph.Method & results: device evaluation and results: the reported device was not returned however a photograph was provided for review.The photograph shows an exeter plug packaging.The photograph shows an outer blister with the tyvek removed on three sides.There is a section of tape on the inner tykek.There is evidence of a good seal.From the photograph provided there is evidence of foreign matter (possibly a hair) on the inner tykek.Medical records received and evaluation: no medical records were received for review with a clinical consultant device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusions: an event regarding foreign matter found in the packaging of an exeter plug was reported.As part of an internal investigation nc was raised for foreign matter in the exeter plug packaging.As part of the investigation "from the investigative actions performed and in the absence of the return of the complaint item (what appeared to be an eyelash), it cannot be conclusively determined that the item is an eyelash and that it did originate at the manufacturer".Gowning procedures and internal sop checks are complaint and adequate.This was determined to be an isolated incident.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
The customer reported that what appeared to be an eyelash was found inside the sterile package.

• Brand Name: EXETER 2.5 I M PLUG 14MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7192699
• Report Number: 0002249697-2018-00163
• Device Sequence Number: 1017145
• Product Code: JDI
• UDI-Device Identifier: 04546540167231
• UDI-Public: 04546540167231
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K980843
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/27/2022
• Device Catalogue Number: 09390114
• Device Lot Number: L8366
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/19/2017
• Supplement Date Received by Manufacturer: 03/14/2018
• Initial Report FDA Received Date: 01/15/2018
• Supplement Report FDA Received Date: 04/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other