MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH STARDRIVE SCREWDRIVER SHAFT T4/42MM/SELF-RETAINING; SCREWDRIVERS

Catalog Number	03.114.002
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient case number reported as (b)(6).Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter phone number and email address are unknown.The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history records review has been requested.(b)(4).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
Device report from synthes europe reports an event in (b)(6) as follows: during an implant placement procedure on (b)(6) 2018, the heads of two titanium (ti) cortex screws broke due to the worn tip of two (2) stardrive screwdriver shafts.All device fragments were easily removed and new screws were implanted to the patient.The procedure was completed successfully with a reported delay of forty five (45) minutes.There is no other reported patient consequence.This report is for a stardrive screwdriver shaft t4/42mm/self-retaining.This is report 2 of 4 for (b)(4).
Additional Manufacturer Narrative
The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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.
Additional 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.A device history record (dhr) review was conducted.Part # 03.114.002 , synthes lot # 7529492 , supplier lot # 7529492, release to warehouse date: 18mar2014 , manufactured by synthes monument.The material was reviewed and the hardness value was confirmed to meet the specification with no (relevant) non-conformance noted.No ncr's were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.A product investigation was conducted.Visual inspection: the t4 stardrive screwdriver (part # 03.114.002, lot # 7529492, mfg 18-mar-2014) was received at us cq with the tip of the screwdriver dull/worn.This agrees with the reported complaint condition, thus confirming the complaint.Dimensional inspection: dimensional analysis was not performed as relevant features are not able to be measured accurately at us cq.A gauge was used for inspecting the lot when manufactured which is not available at us cq.Document/specification review: the relevant drawing(s) was reviewed; review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Conclusion: the complaint condition is confirmed as the device (part # 03.114.002, lot # 7529492 was received with the tip of the screwdriver looking dull/worn.There is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the device encountered unintended forces or could be worn from repeated use over 4 years.No new malfunctions were observed during the course of this investigation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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 SHAFT T4/42MM/SELF-RETAINING
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7681196
• Report Number: 8030965-2018-54955
• Device Sequence Number: 13834972
• Product Code: HXX
• UDI-Device Identifier: 10886982072993
• UDI-Public: (01)10886982072993
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/14/2018

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: 03.114.002
• Device Lot Number: 7529492
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2018
• Initial Date Received by Manufacturer: 06/14/2018
• Supplement Date Received by Manufacturer: 09/24/2018; 10/04/2018
• Initial Report FDA Received Date: 07/12/2018
• Supplement Report FDA Received Date: 10/03/2018; 10/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1