MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 8MM TI MULTILOC PROX HUMERAL NAIL/LEFT/CANN/160MM-STER; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.016.035S

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2018

Event Type  malfunction  

Manufacturer Narrative

Review of the device history records 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 europe reports an event in (b)(6) as follows: it was reported that during an open reduction internal fixation procedure for a proximal humeral fracture on (b)(6) 2018, the upper edge of the multiloc proximal humeral nail was broken.The issue occurred after the surgeon inserted the nail but extracted it because the medullary cavity was very thin.The nail was removed while the connecting screw was loosened.The procedure was completed successfully with another multiloc proximal humeral nail and with a delay of approximately 90 minutes.There was no adverse consequence to the patient reported concomitant device: connecting screw (part unknown, lot unknown, quantity unknown).This report is for one (1) multiloc proximal humeral nail.This is report 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.H10 additional narrative: h3, h4, h6: device history lot.Part: 04.016.035s.Lot: l873036.Manufacturing site: mezzovico.Release to warehouse date: 26.Jun.2018.Expiry date: 01.Jun.2023.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.The raw material certificate was reviewed and the used material was according to specification for implants for surgery.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.Manufacturing investigation summary: a visual inspection has been performed and it confirmed that the received condition agrees with the complaint condition but no visual defects manufacturing related have been identified on returned item.The dimensional re-inspection, the raw material certificate review and the document/specification review didn¿t identify any manufacturing defect or deficiency, thus the manufacturing complaint investigation is considered as not manufacturing related.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: 8MM TI MULTILOC PROX HUMERAL NAIL/LEFT/CANN/160MM-STER
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8196221
• MDR Text Key: 131482904
• Report Number: 8030965-2018-59245
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819431034
• UDI-Public: (01)07611819431034
• Combination Product (y/n): N
• 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: 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2023
• Device Catalogue Number: 04.016.035S
• Device Lot Number: L873036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Date Manufacturer Received: 12/28/2018
• Patient Sequence Number: 1