MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN UNIVERSAL EXTRACTION KIT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number UNK_KIE

Device Problems Off-Label Use (1494); Component Missing (2306)

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

Event Date 01/10/2022

Event Type  malfunction  

Event Description

As reported: "kit team reported that in kit set from trauma: extraction large (d13e01, e031) has drills from non stryker manufacturer.After the zoom/magnifier of drill the manufacturer is: erbauer.The oldest picture of the kit set with non stryker drills which was found via kit team is from (b)(6) 2022.From this time these kit sets were shipped to a customers - the list of the customers in attachment email from kit manager.".

Manufacturer Narrative

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

Manufacturer Narrative

Please note the correction to d9/h3 as the device was not returned for evaluation.Please also note the corrections to h6 device and h6 method codes.The reported event could be confirmed as the received pictures do show non stryker drill bits.A device inspection was not possible since the affected device was not returned.However, a product inspection is anyway not considered necessary as the affected drill bit is not a stryker device, the drill bit is from a manufacturer named "erbauer".This complaint is related to a local service issue as the kits are checked and distributed locally, therefore a non-conformity was opened in poland to address this issue.The complaint is finally not product related and therefore no further evaluation will be performed.Device disposition unknown.

Event Description

As reported: "kit team reported that in kit set from trauma: extraction large (d13e01, e031) has drills from non stryker manufacturer.After the zoom/magnifier of drill the manufacturer is: erbauer.The oldest picture of the kit set with non stryker drills which was found via kit team is from (b)(6) 2022.From this time these kit sets were shipped to a customers - the list of the customers in attachment email from kit manager.".

• Brand Name: UNKNOWN UNIVERSAL EXTRACTION KIT
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 16440724
• MDR Text Key: 310413419
• Report Number: 0009610622-2023-00065
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: PL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• 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?: No
• Date Manufacturer Received: 04/04/2023
• 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