MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HELICAL BLADE/SCREW COUPLING SCREW ROD,FIXATION,INTRAMEDULLARY

Model Number 03.037.026

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 05/29/2018

Event Type  malfunction  

Manufacturer Narrative

There was no known reported patient involvement associated with the complained event. This an instrument and is not implanted/explanted. The subject device has been received and the product evaluation is in progress. No conclusion can be drawn. A review of the device history records has been requested and is currently pending completion. 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

It was reported that on (b)(6) 2018, the connecting rod would not thread into the lag screw inserter when setting up for a case. Another set was opened and used for the surgery. There was no patient involvement. This report is for one (1) helical blade/screw coupling screw. This is report 2 of 2 for complaint (b)(4).

Manufacturer Narrative

Additional narrative: a device history record (dhr) review was conducted for part: 03. 037. 026, lot: 9670717: manufacturing site: (b)(4), release to warehouse date: 08. Oct. 2015: the device history record shows this lot of 80 pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted. This lot met all dimensional, visual and functional criteria at the time of release with no issues documented during the manufacturing process. Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition. A product investigation was conducted. Visual inspection: visual inspection performed on the returned coupling screw observed no issues except for the minor signs of wear that doesn¿t impact product functionality. However, deformation issue was identified on the mating device. Functional inspection: functional inspection performed showed coupling screw being stuck at its proximal shaft portion when inserted into the screw inserter due to the inserter's deformed mating surfaces. The complaint condition was able to be replicated at the customer quality and the complaint condition was confirmed. However, no issues were identified with the returned coupling screw. Drawing review: based on the date of manufacture the relevant drawings, reflecting the current and manufactured revision, were reviewed. Dimensional analysis and document/specification review: dimensional inspection performed on the diameter of the mating shaft diameter measured and falls within the specification per relevant drawings. Conclusion: a definitive root cause for the complaint condition could not be determined from the provided information. However, it is likely that use of given device with a deformed mating device during usage could have contributed to this complaint condition. The overall complaint condition is confirmed; however, no product design issues or manufacturing discrepancies were identified during 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: HELICAL BLADE/SCREW COUPLING SCREW
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7627134
• MDR Text Key: 112037145
• Report Number: 2939274-2018-52582
• 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,health
• Type of Report: Initial,Followup
• Report Date: 05/29/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 03.037.026
• Device Catalogue Number: 03.037.026
• Device Lot Number: 9670717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2018

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No