MAUDE Adverse Event Report: STRYKER TRAUMA KIEL (MDR) LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X40 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 18965040S

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 04/14/2015

Event Type  malfunction  

Event Description

It was reported that the external labels don't match, lateral versus front and back.

Manufacturer Narrative

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

Manufacturer Narrative

Investigation summary: product inquiry states both locking screws, fully threaded t2 tibia ø5x40 mm to be the subject products.A review of the dhr revealed no discrepancies and the items were documented as faultless prior to distribution.The image provided showed discrepancies between side and bottom label regarding the cat.#.The label at the bottom side presents cat.# 18965040s (expiry date 2019-11) and the side labels present cat.# 18965045s (expiry date 2019-11) [1].Optical evaluation, based on the image provided, revealed that the overwrap-foil is no stryker kiel standard as no perforation could be verified and further, sealing seams are visible at one longitudinal side, which is not originally provided at this area.Furthermore, small stickers with stryker imprint are visible under the foil at both longitudinal sides, which is not originally provided by the manufacturer as well.Thus, it is obvious that the packaging was re-wrapped, which is beyond the manufacturer¿s control.Most likely the mix-up of the upper and lower parts occurred during the re-wrapping of the devices.Additionally, the whole packaging process for the screws ø5x40 mm cat.# 18965040s (lot code k073b1a), in particular the labelling, was performed at our supplier dot.For the screw ø5x45 mm cat.# 18965045s (lot code k05241d) the packaging was performed at stryker kiel.Thus, a manufacturing error resp.A mix-up at the manufacturing site could be excluded.The root cause was already given in the cancelled product return child.According to further information received ¿when the pi was opened, stryker brazil also started an internal investigation and we concluded there was a misunderstood in the logistic operator.Corrective actions will be taken by stryker brazil.No products will be returned for investigation¿.This inquiry does not present a complaint regarding product quality and is neither device nor manufacturing related.It rather reflects a deficiency in the further treatment respectively in the flow at distribution site.The event was not caused by product deficiency.Device was never returned.

Event Description

It was reported that the external labels don't match, lateral versus front and back.

• Brand Name: LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X40 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: 4763312
• MDR Text Key: 5797988
• Report Number: 0009610622-2015-00237
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K032244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor,distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/24/2015

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: Lay User/Patient
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 18965040S
• Device Lot Number: K073B1A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/24/2015
• Initial Date FDA Received: 05/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2014
• 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