MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC BUTTRESS/COMPRESSION NUT FOR 357.369; APPARATUS, TRACTION, NON-POWERED

Model Number 357.371

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter is synthes sales representative.Part 357.371, lot 7681977: release to warehouse date: october 09, 2014.Supplier: (b)(4).Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.A product investigation was completed: upon visual inspection, it was observed that the device interface feature (distal end railing) edge was slightly deformed.No other damages were observed on the device except normal wear which would not contribute to the reported complaint condition.The function test was performed with the returned complaint device (buttress/compress nut) and the mating device (130 deg aiming arm: 357.366).During the functional test, the mating device was assembled with the complaint device and it was observed that assembly was too loose as the devices were not interfaced as intended.The alleged device interaction issue was caused due to the interface features deformation in both mating and complaint devices.Thus, the complaint condition was confirmed for the received device.The dimensional inspection was not performed as the complaint relevant dimensions cannot be checked for dimensional accuracy due to the post-manufacturing damage.The relevant drawings reflecting current and manufactured revisions were reviewed.The overall complaint was confirmed for the received device as the complaint device was unable to assemble with the mating device as intended.The resulted device interaction issue was occurred due to the deformed interface features in both mating and complaint devices.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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 on (b)(6) 2020, the patient underwent an unknown procedure.During the procedure, the buttress/compression nut and the aiming arm would not click in.The procedure was successfully completed with no surgical delay.There was no patient consequence.This report is for a buttress/compression nut.This is report 2 of 2 for (b)(4).

• Brand Name: BUTTRESS/COMPRESSION NUT FOR 357.369
• Type of Device: APPARATUS, TRACTION, NON-POWERED
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 10922867
• MDR Text Key: 218978320
• Report Number: 2939274-2020-05364
• Device Sequence Number: 1
• Product Code: HST
• UDI-Device Identifier: 10886982196057
• UDI-Public: (01)10886982196057
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 357.371
• Device Catalogue Number: 357.371
• Device Lot Number: 7681977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2014
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS