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

Catalog Number	0113120
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned and visually evaluated.It was confirmed that the screw had not been fully secured in the handle and came loose as was reported.Thread tap markings were missing from the handle where the screw was inserted.Based on our evaluation we have identified the most likely root cause to be manufacturing related.To date, this is the first complaint for this production lot of (b)(4) units released for distribution in july of 2017.A review of complaint history finds this to be the only report of a misassembled screw for the permafix fixation devices.
Event or Problem Description
It was reported that during a procedure, a screw in the handle of the permafix fixation product came loose.The screw was retrieved.There was no patient injury reported.

• 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: 8981772
• Report Number: 1213643-2019-08550
• Device Sequence Number: 16962922
• Product Code: GDW
• UDI-Device Identifier: 00801741016721
• UDI-Public: (01)00801741016721
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K111153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• 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: 06/28/2020
• Device Catalogue Number: 0113120
• Device Lot Number: HUBT0412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2019
• Initial 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