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

Catalog Number UNK_KIE

Device Problem Difficult to Remove (1528)

Patient Problems Discomfort (2330); Foreign Body In Patient (2687); Implant Pain (4561)

Event Date 03/31/2023

Event Type  Injury  

Event Description

As reported: "used timex extraction kit for proximal humeral nail removal.The nail would not come out using the usual conical extractor.The male extractor 4mm was used to try clear bone inside the nail and broke whilst trying to extract nail.The broken part remains in the nail.Unable to extract nail and had to leave the nail in patient.Nb: the male extractor would not usually be used in this situation however nothing else was working therefore it was attempted to force the nail out in other ways.The patient had already been on the table for approximately 2 hours trying to extract the nail before the male extractor broke." additional information: the patient wanted it removed as they had discomfort when raising their arms up, it was thought the nail was not buried enough however once opened, the top of the nail was firmly buried beneath bone.It was a planned removal due to patient discomfort and the surgeon is not planning to make another attempt to remove the nail.

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned and no additional information was available.A device inspection was not possible since the affected device was not returned and no other evidences were provided for investigation.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 did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was 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 remains implanted.

• Brand Name: UNKNOWN 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: 17019192
• MDR Text Key: 316119578
• Report Number: 0009610622-2023-00177
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_KIE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/04/2023
• 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
• Patient Outcome(s): Other