MAUDE Adverse Event Report: STRYKER TRAUMA KIEL HUMERAL NAIL T2 HUMERUS Ø7X220 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1830-0722S
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/09/2018
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
Or manager at the hospital, reported the following event to the sales rep : "during a t2 nail implantation, the nail fractured during installation, at the junction with the nail holder.The surgeon had to remove the nail and placed another one (length with 10 mm difference because only 1 nail of each size was available).Delay of 2 hours due to this event.No adverse consequences for the patient.
Additional Manufacturer Narrative
The reported event that humeral nail t2 humerus ø7x220 mm was alleged of issue k-250 (implant - humeral nail, deformed / damaged / bent) could be confirmed, since the device was returned for evaluation matches with the alleged failure mode.The device inspection was done and it was observed that the peg of the nail was damaged.Detail inspection of the damaged surface of the peg revealed scratch marks, and that the peg was teared of from its base on nail.Such a damage along with the shape and the location of the scratch is caused when the target device is not assembled properly onto the nail.The operative technique provides instruction on the assembly of the nail that ¿the selected nail is assembled onto the target device (1806-0143) with the nail holding screw (1806-0163).Tighten the nail holding screw securely with the insertion wrench (1806-0135) so that it does not loosen during nail insertion¿.It also clearly mentions that ¿it offers guidance that you should heed, but, as with any such technical guide, each surgeon must consider the particular needs of each patient and make appropriate adjustments when and as required.A workshop training is recommended prior to first surgery.¿ thus based on the investigation the root cause can be attributed to a user related issue and the root cause is failure to follow the operative technique and improper assembly of the alleged product.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.If any further information is provided, the investigation report will be updated.
Event or Problem Description
Or manager at the hospital, reported the following event to the sales rep : "during a t2 nail implantation, the nail fractured during installation, at the junction with the nail holder.The surgeon had to remove the nail and placed another one (length with 10 mm difference because only 1 nail of each size was available).Delay of 2 hours due to this event.No adverse consequences for the patient.

• Brand Name: HUMERAL NAIL T2 HUMERUS Ø7X220 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: 7462871
• Report Number: 0009610622-2018-00192
• Device Sequence Number: 11160873
• Product Code: HSB
• UDI-Device Identifier: 04546540201287
• UDI-Public: (01)04546540201287
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K032523
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2018

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: 02/28/2022
• Device Model Number: 1830-0722S
• Device Catalogue Number: 18300722S
• Device Lot Number: K02A8C7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2018
• Initial Date Received by Manufacturer: 04/09/2018
• Supplement Date Received by Manufacturer: 07/05/2018
• Initial Report FDA Received Date: 04/25/2018
• Supplement Report FDA Received Date: 07/31/2018
• 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