MAUDE Adverse Event Report: SYNTHES TUTTLINGEN STRAIGHT BALL SPIKE FOR LOW PROFILE PELVIC SYSTEM-LONG; RETRACTOR

Catalog Number	03.100.019
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient involvement was reported.Operator type was reported as lay user.Device is an instrument and is not implanted / explanted.Device is expected to be returned for manufacturer review/investigation, but has not been received yet.(b)(6).Service history review was completed for part# 03.100.019, lot# t955017.No service history review can be performed as part number 03.100.019 with lot number(s) t955017 is a lot/batch controlled item.The manufacture date of this item is 19-oct-2010.The source of the manufacture date is the release to warehouse date.The service history review is unconfirmed.Device history records review was completed for part# 03.100.019, lot# t955017.Manufacturing location: (b)(4), manufacturing date: oct 13, 2010.Review of the device history record of (b)(4) showed that there were no issues at the time of manufacturing of this device that would contribute to the issue outlined in this complaint.A review of inspection records and certifications, confirm that the components and final product met inspection records.All (b)(4) parts of the lot were checked 100% for important features at the final inspection on oct 12, 2010.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.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
(b)(6) reported the following: it was reported that following three (3) instruments were identified as damaged.A ball spike pusher tip is broken and two depth gauges have prongs which are broken.This was noticed in the sterile processing department.No procedure or patient involvement was reported.This report is for one (1) straight ball spike for low profile pelvic system-long.This is report 1 of 3 for (b)(4).

• Brand Name: STRAIGHT BALL SPIKE FOR LOW PROFILE PELVIC SYSTEM-LONG
• Common Device Name: RETRACTOR
• Manufacturer (Section D): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• MDR Report Key: 6384144
• Report Number: 9680938-2017-10036
• Device Sequence Number: 16278662
• Product Code: GAD
• UDI-Device Identifier: 10886982070685
• UDI-Public: (01)10886982070685(10)T955017
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/08/2017

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: 03.100.019
• Device Lot Number: T955017
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2017
• Initial Report FDA Received Date: 03/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1