MAUDE Adverse Event Report: STRYKER GMBH METACARPOPHALANGEAL SIZER, SIZE 50 SILICONE MCP; PROSTHESIS, FINGER, CONSTRAINED, POLYMER23

Catalog Number MCP505

Device Problem Leak/Splash (1354)

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

Event Date 02/10/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device will not be returned.If additional information becomes available it will be provided on a supplemental report.The device is not available to stryker.

Event Description

Rep states the red mcp trial is leaking dye.The mcp-505 red trial was taken from the instrument tray as received and cleaned once using a swab with rubbing alcohol and again with a swab using acetone.Additionally the trial was wrapped and placed in the instrument set and subjected to a standard autoclave cycle.No leaching of any red dye was observed.After completion of the autoclave cycle, the wrapped trial was inspected and found to be free of any discoloration.

• Brand Name: METACARPOPHALANGEAL SIZER, SIZE 50 SILICONE MCP
• Type of Device: PROSTHESIS, FINGER, CONSTRAINED, POLYMER23
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5328825
• MDR Text Key: 35008570
• Report Number: 0008031020-2015-00651
• Device Sequence Number: 1
• Product Code: KYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K870200
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MCP505
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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