MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC RADIOLUCENT AIMING ARM/FRN PIRIFORMIS FOSSA ROD,FIXATION,INTRAMEDULLARY

Model Number 03.033.002

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Initial reporter is synthes sales consultant. Dhr review was completed. Part: 03. 033. 002. Lot: l750748. Manufacturing site: (b)(4). Release to warehouse date: (b)(6) 2018. The device history record shows this lot of 11 pieces was processed through the normal manufacturing and inspection operations with no rework or relevant nonconformities noted. This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacturing process. Only top level of the device history record reviewed as sub-components are not lot tracked. Further review has shown that the non-conformity was created as one piece of this lot did get damaged on the transportation between haegendorf and monument. The damaged piece has been discarded and the remaining 11 pieces were re-inspected and no damage was detected. Therefore it is unlikely that this transportation damage is relevant for the complaint condition. However, a final conclusion is only possible after a physical evaluation of the device. The investigation could not be completed; no conclusion could be drawn, as no product was received. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. 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, while assembling the set for the first time, the radiolucent aiming arm was found broken in the original package. There was no patient or surgical involvement. This report is for one (1) radiolucent aiming arm. This is report 1 of 1 for pc-(b)(4).

• Brand Name: RADIOLUCENT AIMING ARM/FRN PIRIFORMIS FOSSA
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8119320
• MDR Text Key: 128930272
• Report Number: 2939274-2018-55179
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172157
• 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,Followup
• Report Date: 11/12/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 03.033.002
• Device Catalogue Number: 03.033.002
• Device Lot Number: L750748
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown