MAUDE Adverse Event Report: STRYKER TRAUMA KIEL PROXIMAL HUMERAL NAIL, CANNULATED, LEFT T2 PROX. HUM. Ø8 X 150 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 1832-1035S

Device Problem Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/02/2021

Event Type  malfunction  

Event Description

The customer reported the following: upon attempting explantation, one of the distal locking pins was found to be cold welded. The bolt had to be exposed ventrally and dorsally and milled off so that the nail could be knocked out of the medullary canal.

Manufacturer Narrative

The device will not be returned. If additional information becomes available, it will be provided in a supplemental report. Device disposition is unknown.

• Brand Name: PROXIMAL HUMERAL NAIL, CANNULATED, LEFT T2 PROX. HUM. Ø8 X 150 MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12743585
• MDR Text Key: 281153735
• Report Number: 0009610622-2021-00771
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K042396
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 06/28/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 1832-1035S
• Device Catalogue Number: 18321035S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2022
• 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