MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI MULTILOC END CAP F/MULTILOC NAIL/0MM EXTENSION-STERILE; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.019.000S

Device Problems Break (1069); Material Twisted/Bent (2981)

Patient Problem Not Applicable (3189)

Event Date 05/08/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A review of the device history record has been requested.The device was 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) 2020, the patient underwent osteosynthesis surgery for proximal humeral fracture with the end cap in question.During the end cap insertion, the surgeon tried to insert the end cap a few times, but he couldn't insert it properly.The surgeon finally gave up inserting the end cap because the thread of the end cap was damaged, and he finished the surgery within 30 minutes delay.No further information is available.This report is 1 of 1 for (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.Visual inspection: upon visual inspection of the complaint device it can be seen that the thread is damaged, deformed and peeled off from use, this thus confirming the complaint description.In addition, the part (incl.Recess) has scratches, dents and deformation all over.Functional test: a functional test is not possible, based on the already mentioned deformation.Dimensional inspection: the investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the device, therefore no dimensional inspection is needed.Document/specification review: drawings and revisions are in accordance to dhr of production lot 30p7018.All relevant features are defined on the used drawing revisions of dhr of production lot 30p7018.Summary: there is no particularize information what's happened to this article by customer, unfortunately we are not able to determine the exact reason for this occurrence, but we assume that during the operation an application error may have taken place or/and that an overloading situation (high applied mechanical force) could have led to this damage.The cause of complained malfunction is a post-manufacturing caused and/or use related, therefore the complaint is rated as confirmed, but not valid from manufacturing point of view.To prevent such problems, it is necessary to operate according to the technique guide.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history: part: 04.019.000s, lot: 30p7018, manufacturing site: mezzovico, release to warehouse date: 07 feb 2019, expiry date: 01.Jan.2030.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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: TI MULTILOC END CAP F/MULTILOC NAIL/0MM EXTENSION-STERILE
• 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: 10078692
• MDR Text Key: 191685329
• Report Number: 2939274-2020-02477
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819431263
• UDI-Public: (01)07611819431263
• Combination Product (y/n): N
• PMA/PMN Number: K103002
• 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: 05/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.019.000S
• Device Lot Number: 30P7018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2020
• Date Manufacturer Received: 06/18/2020
• Patient Sequence Number: 1