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

Catalog Number MCP20

Device Problems Break (1069); Product Quality Problem (1506); Incorrect Device Or Component Shipped (2962)

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

Event Date 04/21/2015

Event Type  malfunction  

Event Description

During finger joint replacement surgery, the surgeon opened the package of pre-flex.When the surgeon took implant out and checked it, he found that the implant is a different product.The straight implant bent and was placed in the package.Therefore, the surgeon changed the implant to another implant.

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.The reported device was manufactured and distributed by (b)(4) and implanted prior to howmedica osteonics corp.¿s purchase of certain assets of (b)(4) on august 1, 2014.Stryker became legal manufacturer of this product on april 1, 2015 and has taken the responsibility for medical device reporting.

Manufacturer Narrative

The reported event that silicone ii mcp implant size 20 (sterile packed) was alleged of issue s-16 (device deformed) could be confirmed although the device was not returned.In fact, a picture showing the reported failure mode was provided.Despite this, the confirmed failure mode is ¿no failure¿.Indeed, as stated by r&d, the pre-bending of the device caused by its positioning in the package is to be considered normal, given the elastic properties of its material, and does not have any negative affect on the performance of the product, since the resiliency of the material would allow it to recoil into its original shape after deformation.Please note that a new blister design that limits part movement has been recently implemented in order to mitigate the occurrence of this failure mode.Notes.Rationale from r&d: ¿the design of silicone mcp standard and preflex implants is identical (including material, process, etc¿) with the exception of a 30° angle generated at the hinge location.These parts are injection molded using a two part silicone elastomer material.By design, the silicone material is very resilient.This characteristic allows for the implant to recoil or ¿spring back¿ into its original shape after bending, stretching, or compressing.The recovery time, or how quickly the material resumes the original shape after deformation, can possibly be influenced by a variety of external factors that include the amount of deformation applied and the duration of time for which the deformation was applied.Therefore it is possible that, if the part was positioned in the inner blister package as shown in the provided photograph, the stems of the part may exhibit an immediate appearance of being ¿angled¿ with one another.However, after a short period of time the part would resume its original shape because of the resiliency of the material as described earlier.The ¿pre-bending¿ of the part caused by its positioning in the package as shown will not have any negative affect on the performance of the product.Actually, the intended function of the device is to bend and flex while implanted in the hand (mcp finger joint).A new blister design that limits part movement has been recently implemented and will mitigate the occurrence of this failure mode.¿ [original statements] 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.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.

Event Description

During finger joint replacement surgery, the surgeon opened the package of pre-flex.When the surgeon took implant out and checked it, he found that the implant is a different product.The straight implant bent and was placed in the package.Therefore, the surgeon changed the implant to another implant.

• 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: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4782921
• MDR Text Key: 5814237
• Report Number: 0008031020-2015-00188
• Device Sequence Number: 1
• Product Code: KYJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K870200
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MCP20
• Device Lot Number: 23758201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/05/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/19/2013
• 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): Other