MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN 11MM REAMER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number UNK_KIE

Device Problems Mechanical Jam (2983); Naturally Worn (2988)

Patient Problems Foreign Body In Patient (2687); Limb Fracture (4518)

Event Date 12/07/2023

Event Type  malfunction  

Manufacturer Narrative

Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.H3 other text : device discarded.

Event Description

The customer reported to ansm the following: "arthroplasty of the right hip.The prosthesis needs to be reamed.Two incidents occur: - reamer 11 gets stuck and deteriorates.- a reamer 13 whose distal part broke off and could not be recovered.Decision to push it into the shaft shaft so that it does not interfere with the rest of the operation.The passage of the reaming piece and the prosthesis requires proximal recutting of the base of the neck, which allows the prosthesis to be lowered.During the prosthesis, the femur fractures.Management of the fracture required posterior disinsertion of the vastus lateralis, which required stitches.Which required hemostasis stitches.There were no other incidents.The operation was completed.Current state of the patient: a piece of non-implantable sterile device has therefore remained in the patient.Risk of bone formation around the piece of reamer and therefore increased risk of fracture.No clinical consequence observed to date.".

Event Description

The customer reported to ansm the following: "arthroplasty of the right hip.The prosthesis needs to be reamed.Two incidents occur: - reamer 11 gets stuck and deteriorates.- a reamer 13 whose distal part broke off and could not be recovered.Decision to push it into the shaft so that it does not interfere with the rest of the operation.The passage of the reaming piece and the prosthesis requires proximal recutting of the base of the neck, which allows the prosthesis to be lowered.During the prosthesis, the femur fractures.Management of the fracture required posterior disinsertion of the vastus lateralis, which required stitches.Which required hemostasis stitches.There were no other incidents.The operation was completed.Current state of the patient: a piece of non-implantable sterile device has therefore remained in the patient.Risk of bone formation around the piece of reamer and therefore increased risk of fracture.No clinical consequence observed to date.".

Manufacturer Narrative

Please note the correction to g1 manufacturing site for devices.The reported event could not be confirmed since the device was not returned for evaluation and no other evidence was provided.A device inspection was not possible since the affected device was not returned and no other evidence was provided for investigation.The batch record could not be reviewed because the affected device was not returned, and the lot number was not communicated.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.A review of the labeling did not indicate any abnormalities.More detailed information such patient¿s medical records and the device itself are needed to determine the exact root cause of the issue.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: UNKNOWN 11MM REAMER
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; postfach; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18653091
• MDR Text Key: 334740549
• Report Number: 0009610622-2024-00056
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• 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?: No
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1