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

Catalog Number	0234020183
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	02/05/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that the product punctured the skin on the users hand.
Event or Problem Description
It was reported that the product punctured the skin on the users hand.
Additional 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
• Common Device Name: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 8379436
• Report Number: 0002936485-2019-00083
• Device Sequence Number: 3014283
• Product Code: NBH
• UDI-Device Identifier: 07613154268276
• UDI-Public: 07613154268276
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Other
• Device Catalogue Number: 0234020183
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/05/2019
• Supplement Date Received by Manufacturer: 02/05/2019
• Initial Report FDA Received Date: 02/28/2019
• Supplement Report FDA Received Date: 07/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other