MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CANN CONNECTING SCR W/INTERNL THRD F/PERCUTAN INSERTN HANDLE; GUIDE

Catalog Number	03.010.146
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received, and the product evaluation is in progress.No conclusion can be drawn.Additionally, device history records review has been requested.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
It was reported that on (b)(6) 2018, before the surgery on titanium cannulated tibial nails expert nailing system, the scrub technician opened the tibial nail expert set.It was noticed that the cannulated connecting screw had the long compression device mechanism incarcerated within the screw.They could separate the two.They used another connecting screw.Patient was not in the room when it was noticed.There was no surgical delay.The procedure was successfully completed.There was no patient consequence.This report is for one (1) connecting screw.This is report 1 of 2 for (b)(4).
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.Device history records review was completed for part: 03.010.146, lot: u206894.Manufacturing location: monument, release to warehouse date: sep 30, 2014.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 investigation was completed.The cannulated connecting screw w/internal third f/percutaneous insertion handle (part # 03.010.146, lot # u206894) was received assembled with the compression device.With use of an appropriately sized hex wrench and assistance with a rubber-gripped glove, the devices were able to be separated.The device had signs of wear consistent with use.No damage was noted to features that interface with the connecting device.Some deformation was noted to the area just above the thread starts to the internal threads: the material deformed distally and away from the threads, i.E.It did not intrude into the threads.This damage was determined to not have contributed to the received/complaint condition, as the material was deformed in a way that would not interfere with the compression device¿s threads and would not interface with any features of the compression device.It was difficult to separate the connecting screw and compression device.The received condition agreed with the complaint description; the complaint was able to be replicated with the returned devices.The minor thread diameter measured 5.00mm, which was within specification of 4.917 - 5.154mm per drawing.Measure using gauge pin gp29.Relevant drawings were reviewed.No design issues were identified.The complaint condition was confirmed during investigation.There were no issues during the manufacture of this product that would contribute to this complaint condition.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive 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: CANN CONNECTING SCR W/INTERNL THRD F/PERCUTAN INSERTN HANDLE
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8262319
• Report Number: 2939274-2019-55954
• Device Sequence Number: 19250623
• Product Code: FZX
• UDI-Device Identifier: 10886982067968
• UDI-Public: (01)10886982067968
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2018

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: 03.010.146
• Device Lot Number: U206894
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2019
• Initial Date Received by Manufacturer: 12/28/2018
• Supplement Date Received by Manufacturer: 02/14/2019
• Initial Report FDA Received Date: 01/18/2019
• Supplement Report FDA Received Date: 02/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1