MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH STARDRIVE SCREWDRIVER T25/SELF-RETAINING; SCREWDRIVERS

Catalog Number 03.010.107

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Occupation: initial reporter is company representative.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, before the surgery with expert tibial nail, the hospital sterilized the screwdrivers and the combined hammer in question.After the sterilization, an unknown brown oily liquid had seeped out and stained a case.The part of the case, in which the phenolic resin product was placed, was stained.The devices were not used in the surgery because a surgeon used a plate.The hospital didn't clean the devices before sterilization.No further information is available.This is report 4 of 4 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h6: a product investigation was conducted.Pre-investigation statement: as reported in the complaint condition after the sterilization, an unknown brown oily liquid had seeped out and stained a case.The reported complaint condition cannot be reproduced anymore at zuchwil customer quality site, due to the actual decontaminated/sterilized condition of the device.However, the device was found with wear and tear signs, hence flow "damage" will be selected for this investigation.Visual inspection: the returned device shows darkened/discolored handle, and a worn driver tip.Furthermore the laser etching on the handle is badly readable.The handle is of canevasit which is susceptible to becoming brittle and darkening after repeated thermal/sterilization/reprocessing cycles.The worn/ discolored canevasit handle and worn driver tip are potential end of life indicators for the returned instrument from normal wear.Summary: the complaint condition is confirmed because of the wear and tear signs.After a visual inspection, it is determined that the reusable instrument is worn from repeated use and servicing; therefore, further investigation for the reported complaint device is not required.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.H3, h4, h6: a device history record (dhr) review was conducted: part: 03.010.107, lot: 3433054, manufacturing site: hägendorf, release to warehouse date: 27.April 2010.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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.

• Brand Name: STARDRIVE SCREWDRIVER T25/SELF-RETAINING
• Type of Device: SCREWDRIVERS
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9025426
• MDR Text Key: 160528680
• Report Number: 8030965-2019-68252
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 07611819760950
• UDI-Public: (01)07611819760950
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.107
• Device Lot Number: 3433054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2019
• Initial Date Manufacturer Received: 08/15/2019
• Initial Date FDA Received: 09/13/2019
• Supplement Dates Manufacturer Received: 09/25/2019
• Supplement Dates FDA Received: 10/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention