MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_RECONSTRUCTIVE_PRODUCT; INSTRUMENT

Catalog Number UNK_REC

Device Problems Difficult to Remove (1528); Sticking (1597)

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

Event Date 02/17/2014

Event Type  malfunction  

Event Description

After placing the im distal resection assembly into the femur surgeon's resident (b)(6) started to pin the block to the femur using a wire driver on stryker system 6 power.While driving the pin into the bone it became stuck in the cutting block and was not able to be removed.

Manufacturer Narrative

Catalogue number unknown at this time.Device description reported as unknown pin.A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

An event regarding pain involving an unknown fixation pin was reported.The event was confirmed.Method & results: -device evaluation and results: a material analysis indicated the pin galled in the guide hole.No material or manufacturing defects were observed on the device features evaluated.-medical records received and evaluation: records were not provided.There is no indication the event is patient related.-device history review: review could not be performed as the device was not properly identified.-complaint history review: review could not be performed as the device was not properly identified.Conclusions: the investigation concluded that the pin galled and seized in the guide hole.A capa was issued and a design change was implemented to add flutes to the bottom half of the pin.The fluted pins will allow the pin to act as a drill bit and clear any burrs or debris located on the inside surfaces of the cutting blocks/guides.The reported pin is contained within the scope of capa.

Event Description

After placing the im distal resection assembly into the femur surgeon's resident (b)(6) started to pin the block to the femur using a wire driver on stryker system 6 power.While driving the pin into the bone it became stuck in the cutting block and was not able to be removed.

• Brand Name: UNKNOWN_RECONSTRUCTIVE_PRODUCT
• Type of Device: INSTRUMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3688810
• MDR Text Key: 4261093
• Report Number: 0002249697-2014-00811
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_REC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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