MAUDE Adverse Event Report: STRYKER GMBH SILICONE II MCP IMPLANT SIZE 20 (STERILE PACKED); PROSTHESIS, FINGER, CONSTRAINED, POLYMER23

Catalog Number MCP20

Device Problem Torn Material (3024)

Patient Problem No Code Available (3191)

Event Date 11/12/2015

Event Type  Injury  

Manufacturer Narrative

The reported device was manufactured and distributed by small bone innovation, inc., (b)(6) and implanted prior to howmedica osteonics corp.¿s purchase of certain assets of sbi on (b)(6) 2014.Stryker became legal manufacturer of this product on (b)(6) 2015 and has taken the responsibility for medical device reporting.Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

Left 4th mcp joint, surgeon wants implant examined for defectiveness, premature degradation of silicone, possible reasons for a tear in the silicone.Upon explanation the surgeon noticed a tear in the silicone on the dorsal surface.Any complicating conditions such as disease or trauma, rheumatoid oa recurrent ulnar subluxation of extensor tendon.Type of replacement device used: mcp 20.".

Manufacturer Narrative

The reported event that silicone ii mcp implant size 20 (sterile packed) was alleged of 'material degraded' could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.Device was not returned.

Event Description

Left 4th mcp joint, surgeon wants implant examined for defectiveness, premature degradation of silicone, possible reasons for a tear in the silicone.Upon explanation the surgeon noticed a tear in the silicone on the dorsal surface.Any complicating conditions such as disease or trauma, rheumatoid oa recurrent ulnar subluxation of extensor tendon.Type of replacement device used: mcp 20.".

• Brand Name: SILICONE II MCP IMPLANT SIZE 20 (STERILE PACKED)
• 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: 5273645
• MDR Text Key: 32899679
• Report Number: 0008031020-2015-00478
• 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,Followup
• Report Date: 02/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: MCP20
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2017
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR