MAUDE Adverse Event Report: STRYKER TRAUMA KIEL PROXIMAL HUMERAL NAIL LONG, RIGHT T2 PROX. HUM. 8X240 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 1832-3824S

Device Problem Difficult to Remove (1528)

Patient Problems Failure of Implant (1924); Limb Fracture (4518)

Event Date 04/08/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The surgeon reported that none of the instruments on the metal extraction fit the proximal humeral nail.He reported that he had already removed the transverse screws, but neither the extraction rod nor the 6mm conical adapter would grab the proximal end of the nail.As a result, the proximal humerus was split to loosen the nail.There was a 75 minute surgical delay as a result of the event.

Event Description

The surgeon reported that none of the instruments on the metal extraction fit the proximal humeral nail.He reported that he had already removed the transverse screws, but neither the extraction rod nor the 6mm conical adapter would grab the proximal end of the nail.As a result, the proximal humerus was split to loosen the nail.There was a 75 minute surgical delay as a result of the event.

Manufacturer Narrative

H6 correction to clinical sign code.The reported event could not be confirmed, since the device was not returned for evaluation and thus, evaluation limited to details available.Due to missing nail a physical inspection of the implant in question was impossible.Returned counterparts were checked for functionality with a sample nail and revealed to be functional as intended.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.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.In case the item and / or substantive information will become available in future that suggests otherwise; the file will be reviewed.

• Brand Name: PROXIMAL HUMERAL NAIL LONG, RIGHT T2 PROX. HUM. 8X240 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
• MDR Report Key: 11773329
• MDR Text Key: 254607943
• Report Number: 0009610622-2021-00503
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540437143
• UDI-Public: 04546540437143
• Combination Product (y/n): N
• PMA/PMN Number: K043404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2023
• Device Model Number: 1832-3824S
• Device Catalogue Number: 18323824S
• Device Lot Number: K03AFBD
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/09/2021
• Initial Date FDA Received: 05/04/2021
• Supplement Dates Manufacturer Received: 07/29/2021
• Supplement Dates FDA Received: 08/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 70