MAUDE Adverse Event Report: STRYKER TRAUMA KIEL T2 PROXIMAL HUMERAL NAIL -LONG NAIL- 260 MM; IMPLANT

Catalog Number UNK_KIE

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Neuropathy (1983); No Code Available (3191); Paresthesia (4421)

Event Date 01/01/2012

Event Type  Injury  

Manufacturer Narrative

The reported event that t2 proximal humeral nail - short nail- 260 mm was alleged of issue adverse impact on patient / patient related / iatrogenic issue, could not be confirmed since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.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.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 polyneuropathy, paraesthesia.The report states, "polyneuropathy with paraesthesia at hands and feet was reported by a (b)(6) caucasian male with diaphyseal humeral fracture treated with t2 phn.The patient therefore wished the removal of the implant.The nail was removed 16 months after the fracture.The fracture was consolidated (#84).".

Event Description

The manufacturer became aware of a 'retrospective data collection report' from bg unfallklinik, murnau, germany.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 polyneuropathy, paraesthesia.The report states, "polyneuropathy with paraesthesia at hands and feet was reported by a 69-year-old caucasian male with diaphyseal humeral fracture treated with t2 phn.The patient therefore wished the removal of the implant.The nail was removed 16 months after the fracture.The fracture was consolidated.(#84)".

Manufacturer Narrative

Please note new information in b2 and h6 (device code, clinical signs code and health impact code) sections.

• Brand Name: T2 PROXIMAL HUMERAL NAIL -LONG NAIL- 260 MM
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 8244376
• MDR Text Key: 132959673
• Report Number: 0009610622-2019-00043
• 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
• Type of Report: Initial,Followup
• Report Date: 12/18/2020

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: Lay User/Patient
• Device Catalogue Number: UNK_KIE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 83