MAUDE Adverse Event Report: STRYKER GMBH PIP INSTRUMENT SET, STARTER AWL SILICONE PIP; PROSTHESIS, FINGER, CONSTRAINED, POLYMER23

Catalog Number 170871

Device Problems Material Deformation (2976); Scratched Material (3020)

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

Event Date 09/18/2013

Event Type  malfunction  

Manufacturer Narrative

With guidance from the mdr policy branch of the fda, mdr reported by stryker (b)(4) as a result of a retrospective lookback of complaints resulting from the acquisition of assets from (b)(4).Device will not be returned.If additional information becomes available it will be provided on a supplemental report.The reported device was manufactured and distributed by (b)(4), howmedica osteonics corp.¿s purchased 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.Device is not available to stryker.

Event Description

The surgeon sees little black particles when he uses the pip 20 proximal broach (b)(4) - the testing conducted and visual examination concludes the particulate is of the same composition as the base material for the broach bit.The particulate may have been from a burr on the bit or generated from the minute deformation that was present at the tip of the bit.The broach has been removed and replaced.Additionally an awl was returned from this set.The handle of the awl exhibited sharp edges from past surgical contact and was removed and replaced.

• Brand Name: PIP INSTRUMENT SET, STARTER AWL SILICONE PIP
• 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: 5331555
• MDR Text Key: 35061436
• Report Number: 0008031020-2015-00727
• Device Sequence Number: 1
• Product Code: KYJ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K931588
• 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: 09/18/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 170871
• Device Lot Number: 17316
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2013
• 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