MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN GAMMA3 NAIL; IMPLANT

Catalog Number UNK_KIE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 09/01/2011

Event Type  Death  

Manufacturer Narrative

This complaint has been reported during a literature review performed by the post market surveillance group.No product identification is possible.Based on the investigation results, no definitive relation could be established between the product and the reported failure adverse consequence.The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information will be provided.If further relevant information becomes available, the investigation will be reevaluated and resubmitted accordingly.Device evaluated by mfr: device disposition is unknown.

Event Description

The manufacturer became aware of a study from (b)(6) orthopedics, (b)(6), united states.The title of this report is ¿enhanced cephalomedullary nail lag screw placement and intraoperative tip-apex distance measurement with a novel computer assisted surgery system¿ and is associated with the stryker adapt & gamma nailing system which was published on october 2016.Within that publication, post-operative complications/ adverse events were reported occurred from 1-september- 2011 to 2-april-2014.It was not possible to ascertain specific device or patient information from the article; 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, 18 complaints were initiated retrospectively for different adverse events mentioned in the study.This product inquiry addresses patient death.8 out of 14 cases.The cause and the date of the death is unknown and will not be disclosed.

• Brand Name: UNKNOWN GAMMA3 NAIL
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8843267
• MDR Text Key: 152705090
• Report Number: 0009610622-2019-00588
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2019
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2019
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death