MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH EXTRACTION SCREW FOR MULTILOC HUMERAL NAILING SYSTEM; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 03.019.024

Device Problem Device-Device Incompatibility (2919)

Patient Problems No Consequences Or Impact To Patient (2199); Not Applicable (3189)

Event Date 01/23/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 on (b)(6) 2020 during an unknown medical device removal that the connection screw for removal of multiloc nail didn¿t really fit in the thread, so they had to use another one from an other system.The surgery was prolonged by 40 minutes.The procedure was completed successfully.This complaint involves one (1) device.This is 1 of 1 for report (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.H3, h4, h6: part: 03.019.024, lot: 9789885, manufacturing site: hägendorf, release to warehouse date: 09.Mar.2016.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: upon visual inspection of the complaint device it can be seen that the part has signs (dents, scratches and deformation) from use, but otherwise the article is in a good condition.Functional test: during investigation a functional test was performed (nail, 04.018.255, 5916075).The extraction screw passed the functional test.Dimensional inspection: the article has passed the function test, no issue could be confirmed, and therefore no dimensional inspection is needed.Document/specification review: drawings and revisions are in accordance to dhr of production lot 9789885.All relevant features are defined on the used drawing revisions of dhr of production lot 9789885.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 have to assume that during the operation an application error may have taken place.To prevent such problems, it is necessary to operate according to the technique guide.The complaint is rated as unconfirmed and not valid from manufacturing point of view, as the part is fully functional and damaged post-manufacturing.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: EXTRACTION SCREW FOR MULTILOC HUMERAL NAILING SYSTEM
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9711488
• MDR Text Key: 191450056
• Report Number: 8030965-2020-01137
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819427242
• UDI-Public: (01)07611819427242
• Combination Product (y/n): N
• PMA/PMN Number: K120807
• 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: 01/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.019.024
• Device Lot Number: 9789885
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2020
• Date Manufacturer Received: 03/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK - NAILS: MULTILOC HUMERAL