MAUDE Adverse Event Report: STRYKER TRAUMA KIEL (MDR) END CAP T2 TIBIA +15 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 18220015S

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 05/27/2015

Event Type  malfunction  

Event Description

It is reported by the nurse of the hospital, that the end cap is wrongly engraved.

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Manufacturer Narrative

Investigation summary: investigation revealed that the device showed an engraving "+5" instead of the intended "+15" on the shaft.All other features of the engraving (catalogue number 1822-0015 and lot code k763315) on the front surface were correct.During review of the dhr no deficiency in dimension it was determined.Further, it was determined that the item in question had been engraved at a sub-supplier on (b)(6) 2011.The engraving program was recorded hand-written being ¿18220015 / +5¿ which corresponds to correct cat-no but to wrong length.Local investigation of the sub-supplier confirmed above discrepancy on (b)(6) 2015.A review of the manufacturer¿s complaint-database and of the capa-database revealed no further matters regarding this lot and regarding other end caps.Thus, it was concluded that the matter was tied to this specific single lot.It was concluded that 100% of the items of this lot were affected.The event of insufficient engraving was analyzed under nc (b)(4).As the affected lot had been in the market for approx.4 years and as no complaint was filed until date (regarding wrong engraving) it was concluded that the user relies on the appearance / actual size and on the engraving on the front surface.The event was caused by a human error during the engraving process.Product was not returned.

Event Description

It is reported by the nurse of the hospital, that the end cap is wrongly engraved.

• Brand Name: END CAP T2 TIBIA +15 MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL (MDR); prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer (Section G): STRYKER TRAUMA KIEL (MDR); prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4854453
• MDR Text Key: 5874101
• Report Number: 0009610622-2015-00305
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K003018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Catalogue Number: 18220015S
• Device Lot Number: K763315
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/27/2015
• Initial Date FDA Received: 06/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other