MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH CANNULATED SCREW MEASURING DEVICE FOR 4.5MM SCREWS; GAUGE,DEPTH

Catalog Number 319.170

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/16/2019

Event Type  malfunction  

Manufacturer Narrative

Reporter is synthes sales consultant.The device has been 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, the surgery was performed with distal femur plate and the direct measuring device in question.The scale of the measuring device was almost disappeared.It was not reported how the surgery was finished.Patient outcome was reported as stable.Concomitant device reported: unknown distal femur plate (part# unknown, lot# unknown, quantity 1).This report is for one (1) cannulated screw measuring device for 4.5 mm screws.This is report 1 of 1 for complaint (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.The received device is in a well-used used condition, the surface is discolored all over from often ¿cleaning and sterilization¿ in these 17 years of use, therefore the scale is not easy to read anymore.(see picture attached 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.End of life definition per important information limits on reprocessing: end of life of a device is normally determined by wear and damage due to use.Evidence of damage and wear on a device may include but is not limited to corrosion (i.E.Rust, pitting), discoloration, excessive scratches, flaking, wear and cracks.Improperly functioning devices, devices with unrecognizable markings, missing or removed (buffed off) part numbers, damaged and excessively worn devices should not be used.No manufacturing related issue was identified and/or confirmed.Based on the investigation findings, it has been determined that no corrective and/or preventative action is appropriate.Device history lot part # 319.17 synthes lot # 4401581.Supplier lot # na.Release to warehouse: 22 may 2002.Manufactured by synthes brandywine.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.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: CANNULATED SCREW MEASURING DEVICE FOR 4.5MM SCREWS
• Type of Device: GAUGE,DEPTH
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8884535
• MDR Text Key: 154105786
• Report Number: 8030965-2019-67126
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 07611819040595
• UDI-Public: (01)07611819040595
• 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: 07/16/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 319.170
• Device Lot Number: 4401581
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2019
• Initial Date Manufacturer Received: 07/16/2019
• Initial Date FDA Received: 08/12/2019
• Supplement Dates Manufacturer Received: 08/28/2019
• Supplement Dates FDA Received: 09/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK - DISTAL FEMUR PLATE