MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN T2 TIBIA NAIL; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number UNK_KIE

Device Problem Difficult to Remove (1528)

Patient Problem Insufficient Information (4580)

Event Date 03/10/2023

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

As reported by the sales rep, "surgeon encountered difficulties in the removal of a t2 tibia nail.It proved impossible to remove the obturator plug and, by extension, the nail despite the use of stryker extraction kits.A left-handed screwdriver, reference (b)(4), broke off in the plug.".

Manufacturer Narrative

The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling was not possible because the catalog number and lot number were not communicated.Indications of material, manufacturing, or design related problems were unable to be identified as the catalog number and lot number were not communicated.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.H3 other text : device disposition unknown.

Event Description

As reported by the sales rep, "surgeon encountered difficulties in the removal of a t2 tibia nail.It proved impossible to remove the obturator plug and, by extension, the nail despite the use of stryker extraction kits.A left-handed screwdriver, reference (b)(4), broke off in the plug.".

Manufacturer Narrative

The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling was not possible because the catalog number and lot number were not communicated.Indications of material, manufacturing, or design related problems were unable to be identified as the catalog number and lot number were not communicated.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.Device disposition unknown.

Event Description

As reported by the sales rep, "surgeon encountered difficulties in the removal of a t2 tibia nail.It proved impossible to remove the obturator plug and, by extension, the nail despite the use of stryker extraction kits.A left-handed screwdriver, reference (b)(4), broke off in the plug.".

• Brand Name: UNKNOWN T2 TIBIA NAIL
• 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: 16697306
• MDR Text Key: 313294480
• Report Number: 0009610622-2023-00107
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: 05/10/2023
• 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