MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. PERMAFIX FIXATION SYSTEM; STAPLE, IMPLANTABLE

Catalog Number	0113120
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
To date, the subject product has not been made available for evaluation.Based on the available information and without a sample to evaluate, we are unable to determine the origin of the stain on the packaging of the device.If the sample is returned for evaluation, this report will be updated.A review of the manufacturing records was performed for the subject lot and found that the lot was manufactured to specification.To date, this is the first reported complaint for the subject lot of (b)(4) units manufactured in august of 2018.Sample has not been returned to date.
Event or Problem Description
It was reported that the permafix fixation device was unpacked in the middle of procedure and it was found that it was contaminated by what was described as a bloodstain inside the package.Problem was noted out of box and the product was not used in the case.The image provided by the user facility shows a stain on the inner side of the sterile pouch.The origin of the stain cannot be determined at this time.
Event or Problem Description
It was reported that the permafix fixation device was unpacked in the middle of procedure and it was found that it was contaminated by what was described as a bloodstain inside the package.Problem was noted out of box and the product was not used in the case.The image provided by the user facility shows a stain on the inner side of the sterile pouch.The origin of the stain cannot be determined at this time.
Additional Manufacturer Narrative
To date, the subject product has not been made available for evaluation.Based on the available information and without a sample to evaluate, we are unable to determine the origin of the stain on the packaging of the device.If the sample is returned for evaluation, this report will be updated.A review of the manufacturing records was performed for the subject lot and found that the lot was manufactured to specification.To date, this is the first reported complaint for the subject lot of 400 units manufactured in august of 2018.Follow up 1 addendum: the subject product was returned for evaluation and a visual examination performed.The foreign material was confirmed and occurred at the pouch manufacturing stage.Root cause was determined to supplier related.Residue smoke/steam from heat resulted in a build up on the exhaust hood which dripped onto the internal layers of the pouch during the manufacturing process.The foreign material visualized was found to be embedded within the seven internal layers of the overall structure of the pouch.The material was location within the internal layers of the pouch and not contacting the permafix device.Updated fields: d.10, g.7, h.2, h.3, h.6, h.10.H11:section a through f the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant /reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: PERMAFIX FIXATION SYSTEM
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 8582180
• Report Number: 1213643-2019-03619
• Device Sequence Number: 19590666
• Product Code: GDW
• UDI-Device Identifier: 00801741016721
• UDI-Public: (01)00801741016721
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K111153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/28/2021
• Device Catalogue Number: 0113120
• Device Lot Number: HUCU2366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2019
• Initial Date Received by Manufacturer: 04/12/2019
• Supplement Date Received by Manufacturer: 08/14/2019
• Initial Report FDA Received Date: 05/06/2019
• Supplement Report FDA Received Date: 09/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1