MAUDE Adverse Event Report: STRYKER GMBH PROXIMAL PHALANGEAL BROACH, SIZE 1 SR PIP; SEMI-CONSTRAINED METAL/POLYMER FINGER JOINT PROSTHESIS

Catalog Number 171325

Device Problems Loose or Intermittent Connection (1371); Contamination /Decontamination Problem (2895)

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

Event Date 03/23/2015

Event Type  malfunction  

Event Description

There where 4 distal size 2 rasps which have been identified to have one of its parts loose.This caused the sterility of the device to be compromised.

Manufacturer Narrative

Once the investigation has been completed, any additional information will be reported in a supplemental report.(b)(4).

Manufacturer Narrative

The reported event that a proximal phalangeal broach, size 1 sr pip has a loose color band could be confirmed.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by inappropriate device maintenance/handling and device useful life exceedance.The reported event occurred on (b)(6) 2015 and the device was manufactured on 12-jun-2008, meaning that it has been in working order for more than 6 years, a significant amount of time.The useful life of re-usable medical devices depends on many factors, including the method and duration of each use and the handling between uses.Careful inspection and functional test of the device before use is the best method of determining the end of serviceable life for the medical device.As proved by the state of the received device, these things were not performed properly.The handle of the device shows several scratches on its low part.The color band can be easily detached from the end cup.The color band is visibly damaged and deformed.It results scratched and discolored in several areas, inside and outside.The tip of the device is intact.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.The cleaning and sterilization guide (ot-rg-1 en rev-2 l24002000 rev.N cleaning & sterilization guide_2015-8332) was reviewed: ''stryker trauma & extremities typically does not specify the maximum number of uses appropriate for re-usable medical devices.The useful life of these devices depends on many factors including the method and duration of each use, and the handling between uses.Careful inspection and functional test of the device before use is the best method of determining the end of serviceable life for the medical device.¿ no indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.

Event Description

There where 4 distal size 2 rasps which have been identified to have one of its parts loose.This caused the sterility of the device to be compromised.

• Brand Name: PROXIMAL PHALANGEAL BROACH, SIZE 1 SR PIP
• Type of Device: SEMI-CONSTRAINED METAL/POLYMER FINGER JOINT PROSTHESIS
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4690914
• MDR Text Key: 5646090
• Report Number: 0008031020-2015-00148
• Device Sequence Number: 1
• Product Code: MPK
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: H980002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 171325
• Device Lot Number: 08320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other