MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MODEL S HAND PIECE ONLY; SKIN GRAFT PRODUCTS

Catalog Number DP0009

Device Problem Energy Output Problem (1431)

Patient Problem Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

Complaint sample was returned for evaluation: dhr - no abnormalities related to the reported failure.Failure analysis - unit delivered without all width clips, power pack, power cord, screwdriver, calibration gauge and wrench.The handpiece does not work.Due to the fact that the drive gear is broken.The thumb switch is very hard to move.Guard plate, eccentric screws and some small parts are worn out.The reported complaint was confirmed through failure analysis.Root cause: the handpiece does not work because the drive gear is broken.Several other components are worn out as well.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.

Event Description

A facility reported that during sampling, there was a sound and the blade of the dermatome stopped functioning.The blade did not vibrate and the skin sample could not be finish correctly.The patient will have a visible scar on the leg (0.5mm depth).The wound was treated with appropriate methods for graft/sampling.It was reported 30 minutes surgical delay (time to replace to another dermatome) and the procedure was completed with the replacement product.

• Brand Name: MODEL S HAND PIECE ONLY
• Type of Device: SKIN GRAFT PRODUCTS
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 11791867
• MDR Text Key: 250185092
• Report Number: 3004608878-2021-00340
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: DP0009
• Device Lot Number: SRH-182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2021
• Date Device Manufactured: 07/19/2016
• 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 Age: 70 YR