MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 7MM TI MULTILOC HUMERAL NAIL RIGHT/CANN/285MM-STERILE; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.016.285S

Device Problems Crack (1135); Device-Device Incompatibility (2919)

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

Event Date 01/01/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information is unknown.Date of event is an unknown date in 2018.Device malfunctioned intra-operatively and was not implanted / explanted.Concomitant medical products: date of concomitant therapy is same as date of event, an unknown date in 2018.Reporter phone number and email address are unknown.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.A device history record 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 Description

Device report from synthes europe reports an event in (b)(6) as follows: during an unknown procedure on an unknown date, it was noticed that the proximal end of the nail had a metal flake that loosened.Also, the inner and outer threads of the insertion handle and the nail do not fit properly.Procedure outcome is unknown.There was no reported patient consequence.Concomitant device: connecting screw/cannulated for multiloc humeral nail (part: 03.019.007, lot: 7562417, quantity: 1).This report is for an 7mm titanium (ti) multiloc humeral nail right/cannulated/285mm-sterile.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

Part: 04.016.285s; lot: 5939502; manufacturing site: (b)(4); release to warehouse date: july 26, 2016; expiry date: july 01, 2021.The device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.Investigation selection investigation site: (b)(4); selected flow: 5.Broken.Visual inspection: the visual inspection has shown that the border on top of the nail is strongly damaged.On one side is a crack of about 4mm length and the border is bent outward.Dimensional inspection: not required per selected investigation flow as root cause is use related.Drawing/specification review: the investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the device, therefore no drawing/specification review is needed.Material review: the material was reviewed, and the value was confirmed to meet the specification with no relevant non-conformance noted.Summary: the evaluation has shown that the border on top of the nail is strongly damaged.On one side is a crack of about 4mm length and the border is bent outward.No fragmentation occurred at the crack; all material is still there.The relevant dimensions cannot be verified anymore due to the damage.The review of the manufacturing documents did show no deviation regarding dimensions or material.This lot was manufactured in july 2016.All parts are shipped, and we are not aware of any other complaint for this part- and lot number combination.These findings speak against any manufacturing related issue.Based on the provided information, we are not able to determine the exact cause of this occurrence.However, the kind of damage with the outward bent border is actually typical for a mechanical overload during the insertion of the nail.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.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: 7MM TI MULTILOC HUMERAL NAIL RIGHT/CANN/285MM-STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SALZBURG; vorgartenstrasse 206b; 1020 WIEN; AU 1020 WIEN
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7905646
• MDR Text Key: 121715333
• Report Number: 8030965-2018-56617
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819501133
• UDI-Public: (01)07611819501133
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K120807
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2021
• Device Catalogue Number: 04.016.285S
• Device Lot Number: 5939502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1