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

Catalog Number	328.010
Medical Device Problem Codes	Fracture (1260); Component Missing (2306); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: RETRACTOR
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• MDR Report Key: 6504286
• Report Number: 3003875359-2017-10192
• Device Sequence Number: 7454
• Product Code: GAD
• UDI-Device Identifier: 10886982191441
• UDI-Public: (01)10886982191441(10)1770416
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/22/2017

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2017
• Initial Report FDA Received Date: 04/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1