MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH HELICAL BLADE INSERTER; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 03.037.024

Device Problem Failure to Align (2522)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/22/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided for reporting.Device is an instrument and is not implanted / explanted.Device history records review was completed for part# 03.037.024, lot# t127814.Manufacturing location: (b)(4), release to warehouse date: mar 02, 2016.No non- conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Product development investigation was completed.The received part was inspected and no damages could be identified.The complete device is in good and faultless condition.No signs of use or wear are visible.The functional test shows full functionality of the inserter.It could be assembled and disassembled as intended.The implant holder turns freely into the handle as intended.The design of the inner part bears a special spring to keep the parts together.A calculated resistance is necessary to disassemble the parts.This is to prevent unforeseen loosening while use.Also, functional test with reference guiding sleeve 03.037.017 was done successfully (the original used device was not returned for investigation).Here it is important to align the colored line marks exactly while insertion.According to disassembling instruction, a trop of oil is required during maintenance.The received condition does not confirm to the complaint description as the parts could be used as intended, no product problem could be identified.The complaint could not be replicated.This complaint is not confirmed.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.

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that on (b)(6) 2018, the open reduction internal fixation was applied to femoral trochanteric fractures.Before the surgery, it was noticed that the three devices (protection sleeve, drill sleeve, and impactor) did not slide smoothly against counterpart devices.These devices were used in the surgery, which was completed with a 30-minute delay.There was no adverse consequence to the patient.Patient outcome was reported as stable.This report is for one (1) helical blade inserter.This is report 1 of 1 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.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: HELICAL BLADE INSERTER
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7613568
• MDR Text Key: 112314785
• Report Number: 8030965-2018-54417
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K131548
• 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: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.037.024
• Device Lot Number: T127814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2018
• Date Manufacturer Received: 06/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1