MAUDE Adverse Event Report: STRYKER TRAUMA KIEL T2 PROXIMAL HUMERAL NAIL - LONG NAIL- 240 MM IMPLANT

Catalog Number UNK_KIE

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Skin Irritation (2076)

Event Date 01/01/2012

Event Type  Injury  

Manufacturer Narrative

The reported event that t2 proximal humeral nail - short nail- 240 mm was alleged of issue implant revision / removal without implant breakage could not be confirmed, since the device was not returned for evaluation and no other evidence was provided. This complaint has been reported during a literature review performed by the post-market surveillance group. No product identification is possible and no additional information will be requested to the customer as this serves for trending purpose. The device inspection was not possible as the product was not returned for investigation. Based on the investigation, no definitive relation could be established between the product and the reported adverse consequence. More detailed information about the complaint event as well as the affected device must be available to determine the root cause of the complaint event. As per complaints history, a t2 humeral nail fixation, as well as any kind of internal fixation of the humerus, bears a significant number of risks in the healing period. The majority of the risks are caused by poor bone quality, poor blood supply of the fragments, and/or poor surgical technique. Typical risks are delayed union, non-union (especially in the distal third of the diaphysis), malunion, and pain. A review of the labeling did not indicate any abnormalities. If any further information is provided, the investigation report will be updated. Device disposition unknown.

Event Description

The manufacturer became aware of a 'retrospective data collection report' from (b)(6). The title of this study is ¿a retrospective data collection of the treatment of humeral fractures with the t2 proximal humeral nailing system (phn)¿ and is associated with the t2 proximal humeral nailing system (phn). Within that publication, post-operative complications/ adverse events were reported, which occurred between 2012 to 2017. It was not possible to ascertain specific device catalogs from the report; a review of the complaint handling database, however, revealed that the events have not been reported by the hospital or by the author of the publication. Therefore, 30 complaints were initiated retrospectively for different adverse events mentioned in the report. This product inquiry addresses hardware irritation (requiring implant removal). 4 out of 5 cases. The report states, "a (b)(6) caucasian female (#70) felt irritation of soft tissue due to proximal screws. The implant was removed 417 days after the implantation. The fracture was reported as consolidated at the time of implant removal. ".

• Brand Name: T2 PROXIMAL HUMERAL NAIL - LONG NAIL- 240 MM
• Type of Device: IMPLANT
• 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: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8244372
• MDR Text Key: 132950680
• Report Number: 0009610622-2019-00041
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional

Reporter Occupation

• Type of Report: Initial
• Report Date: 01/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNK_KIE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 01/14/2019 Patient Sequence Number: 1