MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN MCP INSTRUMENT; IMPLANT

Catalog Number UNK_SEL

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

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

Event Date 08/20/2018

Event Type  malfunction  

Manufacturer Narrative

Device will not be returned.If additional information becomes available it will be provided on a supplemental report.

Event Description

Customer reported that during surgery, the mcp instrument was available for use instead of the pip instrument.The surgeon only realized with the patient asleep on the table and with the hand opened.The surgeon then proceeded to try his best to implant 2 x pip implants however this was unsuccessful and the patient will need relisted.

Event Description

Customer reported that during surgery, the mcp instrument was available for use instead of the pip instrument.The surgeon only realized with the patient asleep on the table and with the hand opened.The surgeon then proceeded to try his best to implant 2 x pip implants however this was unsuccessful and the patient will need relisted.

Manufacturer Narrative

The reported event that unknown_selzach_product was alleged of 'mix-up' could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.Based on investigation, the root cause was attributed to be user related.The failure was caused by an improper preparation before surgery.It remains hospital responsibility to check instrumentation prior to surgery.It is customer responsibility to check proper functionnality and that complete instrumentation is available before surgery.A review of the device history was not possible because the lot number was not communicated.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.

• Brand Name: UNKNOWN MCP INSTRUMENT
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7883136
• MDR Text Key: 120829192
• Report Number: 0008031020-2018-00605
• Device Sequence Number: 1
• Product Code: KYJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other