MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP ZYPHR DISP CRAN PERF LRG 14/11; DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)

Catalog Number 5100060001

Device Problem Material Disintegration (1177)

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

Event Date 03/31/2024

Event Type  malfunction  

Manufacturer Narrative

This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events.1 event was reported for this quarter.Product return status.1 device investigation type has not yet been determined.Additional information.1 device was labeled for single-use.1 device was not reprocessed or reused.

Event Description

This report summarizes 1 malfunction event in which the device was shedding metal debris.- 1 event had patient involvement; no patient impact.

Event Description

This report summarizes 1 malfunction event in which the device was shedding metal debris.1 event had patient involvement; no patient impact.

Manufacturer Narrative

This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale: 1 previously reported event is included in this follow-up record.Product return status: 1 device was evaluated using data provided by the user or a third party.

• Brand Name: ZYPHR DISP CRAN PERF LRG 14/11
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-IRELAND; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA
• Manufacturer Contact: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 19113240
• MDR Text Key: 340821997
• Report Number: 3015967359-2024-00693
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 5100060001
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/31/2024
• Initial Date FDA Received: 04/15/2024
• Supplement Dates Manufacturer Received: 03/31/2024
• Supplement Dates FDA Received: 07/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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