MAUDE Adverse Event Report: SYNTHES HAGENDORF SOFT TISSUE RETRACTOR LARGE EXTENDIBLE

Catalog Number 328.010

Device Problems Fracture (1260); Component Missing (2306); Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: there was no reported patient involvement associated with the complained event.Event date: unknown.Device is an instrument and is not implanted/explanted.A service and repair evaluation was performed for the returned subject device.The customer reported the soft tissue retractor was missing a piece.The repair technician reported the blade was missing, and the locking nut was chipped and missing a piece.¿missing parts¿ is the reason for repair.The cause of the issue is unknown.The following parts were replaced: locking nut, blade.The item was repaired per the inspection sheet, passed synthes final inspection on apr 11, 2017 and will be returned to the customer upon completion of the service and repair process.The service and repair evaluation confirmed the complaint condition.A service history record review was performed for the subject device.The previous service event for part number 328.010 with lot number(s) 1770416 has been reviewed.No service history review can be performed as the item has not previously been sent in for service.There is no relevant information to the current complained issue.A device history record review was performed for the subject device lot.Manufacturer: synthes (b)(4).Date of manufacture: nov 26, 2007.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was initially reported that a soft tissue retractor device was found to be missing a piece upon inspection after sterile processing.It is unknown when the component piece was lost.There was no reported patient or surgical involvement.This event was initially determined to be a non-reportable event.Upon return of the instrument to the synthes manufacturer, the repair technician reported the blade was missing, and the locking nut was chipped and missing a piece.The event was reevaluated and determined to be reportable.This report is 1 of 1 for (b)(4).

• Brand Name: SOFT TISSUE RETRACTOR LARGE EXTENDIBLE
• Type of Device: RETRACTOR
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6504286
• MDR Text Key: 73259062
• Report Number: 3003875359-2017-10192
• Device Sequence Number: 1
• Product Code: GAD
• UDI-Device Identifier: 10886982191441
• UDI-Public: (01)10886982191441(10)1770416
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 328.010
• Device Lot Number: 1770416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2007
• 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