MAUDE Adverse Event Report: UMKIRCH SAW BLADE 46/25*6*0.6/0.4 AO/ASIF-COUPL; BLADE, SAW, GENERAL AND PLASTIC SURGERY, SURGICAL

Catalog Number 519.230

Device Problem Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 01/25/2017

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: (b)(4).Reporter¿s complete mailing address is unknown.Reporter¿s phone number is unknown.The actual device was returned for evaluation.The device was evaluated and the reported condition was confirmed.The assignable root cause was determined to be due to corrosion from improper cleaning and maintenance which is user error/misuse/abuse.If additional information should become available, a supplemental medwatch will be submitted accordingly.

Event Description

It was reported from (b)(4) that the saw blade device had possible oxidation (black butt on tip).During in-house engineering evaluation, it was determined that the saw blade had black discolorations and damaged dents.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Type of Device: BLADE, SAW, GENERAL AND PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): UMKIRCH; im kirchenhurstle 4; umkirch b. freiburg D-792 24; GM D-79224
• Manufacturer (Section G): UMKIRCH; im kirchenhurstle 4; umkirch b. freiburg D-792 24; GM D-79224
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6567111
• MDR Text Key: 75169264
• Report Number: 8030965-2017-12345
• Device Sequence Number: 1
• Product Code: GFA
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K971544
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Service and Testing Personnel
• Type of Report: Initial
• Report Date: 01/25/2017

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 Operator: Health Professional
• Device Catalogue Number: 519.230
• Device Lot Number: 9911410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/19/2017
• Initial Date FDA Received: 05/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1