MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X52,5 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 18965052S

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 06/29/2017

Event Type  malfunction  

Manufacturer Narrative

The returned device matched the report and the complaint failure mode was confirmed. Referring to product inquiry the locking screw, fully threaded t2 tibia ø5x52,5 mm [packaging] is stated to be the primary product. No further associated products were reported. A review of the dhr revealed no discrepancies, in particular during the packaging process. During visual inspection a hair outside the sterile barrier between overwrap-foil and cardboard box could be verified. All seals and original packaging are still intact. Thus, the pollution must have occurred during the packaging process at our sub-supplier, which was not detected during inspection. Based on the above facts the root cause of the reported event is related to an inadequate packaging process. Review of complaint history, capa databases and risk analysis did not identify any conspicuity. The review of the risk assessment for the failure mode indicated the issue was addressed adequately. The found hair has to be classified as a non-conformance. This case has to be classified as a non-conformance and ncr has been initiated for further root cause investigation.

Event Description

During the receiving process at stryker escs bv in venlo it was noticed that the product was received with a hair under the sealing foil.

Manufacturer Narrative

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

Event Description

During the receiving process at stryker escs bv in venlo it was noticed that the product was received with a hair under the sealing foil.

• Brand Name: LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X52,5 MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6731361
• MDR Text Key: 251446565
• Report Number: 0009610622-2017-00232
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K003018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 09/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 18965052S
• Device Lot Number: K09435A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2017
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 07/21/2017 Patient Sequence Number: 1