MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC UNKNOWN BATTERY POWERED HANDPIECES; IMPACTOR, ADAPTERS, BATTERY, BATTERY CHARGER

Catalog Number UNK-BATTERY-POWERED-HANDPIECES

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: d1, d4, g1, g4 (510k), h4: this report is for an unknown battery powered handpiece device.Part and lot number are unknown.Without the specific part number; the expiration date, udi number, 510-k number, manufacturing site name, and device manufacture date are unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h6: without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

This report is being filed to review the following journal article: "does powered femoral broaching compromise patient safety in total hip arthroplasty?" the article describes the complications associated to the power broaching group as follows: trochanteric fractures = 4.Calcar fractures = 12.Femoral canal perforations = 3.Total fractures = 19.All were appropriately treated at the time of surgery.A copy of the literature article is attached to this medwatch report.

• Brand Name: UNKNOWN BATTERY POWERED HANDPIECES
• Type of Device: IMPACTOR, ADAPTERS, BATTERY, BATTERY CHARGER
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): TECHTRONIC INDUSTRIES MEDICAL; 1428 pearman dairy rd; anderson SC 29625
• Manufacturer Contact: kate karberg ; 4500 riverside drive; palm beach gardens, FL 33410 ; 3035526892
• MDR Report Key: 17871759
• MDR Text Key: 324932678
• Report Number: 1045834-2023-01429
• Device Sequence Number: 1
• Product Code: GEY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK-BATTERY-POWERED-HANDPIECES
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening