MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE TIBIAL DRILL GUIDE DOUBLE POINT FORKED ARM; ACCESSORIES, ARTHROSCOPIC

Catalog Number 0234020183

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Needle Stick/Puncture (2462)

Event Date 02/05/2019

Event Type  Injury  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.

Event Description

It was reported that the product punctured the skin on the users hand.

Event Description

It was reported that the product punctured the skin on the users hand.

Manufacturer Narrative

The product was not returned for investigation; therefore, the reported failure mode was not confirmed.The reported failure mode will be monitored for future reoccurrence.Alleged failure: sharps injury.Probable root cause: design -non-cutting edges are sharp process -devices manufactured out of specification -deburring step not completed application -user carelessness with sharp instrument.The device manufacture date is not known.

• Brand Name: TIBIAL DRILL GUIDE DOUBLE POINT FORKED ARM
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 8379436
• MDR Text Key: 137452132
• Report Number: 0002936485-2019-00083
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 07613154268276
• UDI-Public: 07613154268276
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 0234020183
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/05/2019
• Initial Date FDA Received: 02/28/2019
• Supplement Dates Manufacturer Received: 02/05/2019
• Supplement Dates FDA Received: 07/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other