MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED S2 Ø5X40 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1796-5040S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that when customer opened a package of a stainless steel screw it was noticed that the package contained a different product (titanium screw k0c971b).
Additional Manufacturer Narrative
The locking screw, fully threaded s2 ø5x40 mm is the only reported device and considered the primary product.A further associated product (the titanium locking screw - allegedly found in the packaging of the primary product) was returned, but was not part of the product inquiry (product grid).Nevertheless, since the issue is about a package which allegedly contained a different product than labelled, the manufacturing documents of the (associated) titanium locking screw have also been reviewed, in particular the packaging / labeling documents; no deviation was found.Likewise, the review of the device history records for the reported locking screw, fully threaded s2 ø5x40 mm (stainless steel) revealed no conspicuities, in particular regarding the packaging / labeling documents.The total quantity of labels used for both locking screws was verified; no deviation was found.Both products were documented as faultless prior to distribution.The reported event could not be confirmed since a mix-up during the packaging process can be excluded.The locking screws were packed at different locations; the time interval between both packaging processes was three weeks.The reported event was not caused by a deficiency of the product(s) resp.By a mislabeling by the manufacturer.Based on the fact, that both items (locking screw, fully threaded s2 ø5x40 mm, catalogue # 17965040s, lot code k07c716 and locking screw, fully threaded t2 tibia ø5x40 mm, catalogue # 18965040s, lot code k0c971b) were delivered to the complaining hospital, a mix-up in the hospital appears more likely than an error during the packaging process, which is precisely documented without indication of deviation.Considering the above observations any review of complaint history and risk analysis was dispensable in this case and any potential corrective / preventive actions have been deemed unnecessary.The root cause of the reported event is not device related.No non-conformity was identified.
Event or Problem Description
It was reported that when customer opened a package of a stainless steel screw it was noticed that the package contained a different product (titanium screw k0c971b).

• Brand Name: LOCKING SCREW, FULLY THREADED S2 Ø5X40 MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 6517298
• Report Number: 0009610622-2017-00123
• Device Sequence Number: 248696
• Product Code: HSB
• UDI-Device Identifier: 04546540399731
• UDI-Public: (01)04546540399731(11)170113(17)211231(10)K07C716
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K032579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: 1796-5040S
• Device Catalogue Number: 17965040S
• Device Lot Number: K07C716
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2017
• Initial Date Received by Manufacturer: 03/28/2017
• Supplement Date Received by Manufacturer: 06/29/2017
• Initial Report FDA Received Date: 04/24/2017
• Supplement Report FDA Received Date: 07/27/2017
• 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