MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN DRILL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number UNK_SEL

Device Problems Overheating of Device (1437); Insufficient Information (3190)

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

Event Date 02/14/2022

Event Type  malfunction  

Manufacturer Narrative

Upon completion of the investigation, additional information will be provided in a supplemental report.

Event Description

The customer reported the following issue: the materialovigilance declaration has not yet been made by the surgeon, it seems that there was a problem with the screw thread and that there was a spark with a visible flame when the drill was inserted." update: (b)(6) 2022: the procedure could be completed correctly by opening the clavicle ancillary to recover the screw racks of the same size.

Event Description

The customer reported the following issue: "the materialovigilance declaration has not yet been made by the surgeon, it seems that there was a problem with the screw thread and that there was a spark with a visible flame when the drill was inserted." update - (b)(6) 2022: the procedure could be completed correctly by opening the clavicle ancillary to recover the screw racks of the same size.

Manufacturer Narrative

Correction: please refer to h6 - device code.The reported event could not be confirmed, since the device was not returned and no additional information was available.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.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.

• Brand Name: UNKNOWN DRILL
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13743271
• MDR Text Key: 288382771
• Report Number: 0008031020-2022-00100
• 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: Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2022
• Was Device Evaluated by Manufacturer?: No
• 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