MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 7MM TI MULTILOC HUMERAL NAIL RIGHT/CANN/240MM-STERILE; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.016.240S

Device Problem Break (1069)

Patient Problem Blood Loss (2597)

Event Date 07/24/2019

Event Type  Injury  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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

Device report from (b)(6) reports an event as follows: it was reported that while inserting a multiloc humerus nail system on (b)(6) 2019, the surgeon heard a sound, checked under live x-ray, and found that part of the nail which is attached with the insertion zig was broken.The surgeon immediately withdrew the nail and used another nail to complete the procedure.There was some amount of blood loss due to the withdrawal of the first nail and insertion of the second.There was a reported surgical delay of thirty (30) minutes.Patient status is unknown.Concomitant devices: insertion instrument (part: unknown, lot: unknown, quantity: 1).This report is for a 7mm titanium (ti) multiloc 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.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.Investigation summary : investigation site: cq zuchwil.Selected flow: damage.Visual investigation: the visual investigation shows a strong deformation without broken off parts or fragments on the connection part at the proximal end of the multiloc humeral nail.The shaft itself is in good condition and shows normal signs of use.Dimensional inspection due to the damages the relevant dimension could not be measured.However the parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements.Document / specification review the manufacturing specification were reviewed, and this lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Investigation conclusion the damages are visible on the received pictures.It was reported that the part of the head from the nail was broken during surgery.Against the complaint description the head section is cracked, but not broken.Unfortunately we are not able to determine the exact cause which has led to the damaged head section.Due to the strong deformation of the proximal end of the multiloc humeral nail we must assume that high force was applied during use.Additionally it can not be excluded that the selected nail diameter was too large, resulting in higher insertion resistance.According the surgical technique dsem!trm/0115/0301 (2) 03/16, two alternatives are possible: if nail insertion is difficult, choose a smaller diameter nail or ream the intramedullary canal to a larger diameter.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 history lot : a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.

• Brand Name: 7MM TI MULTILOC HUMERAL NAIL RIGHT/CANN/240MM-STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8922935
• MDR Text Key: 156280177
• Report Number: 8030965-2019-67654
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819431102
• UDI-Public: (01)07611819431102
• 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: 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2022
• Device Catalogue Number: 04.016.240S
• Device Lot Number: 5944662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2019
• Date Manufacturer Received: 08/22/2019
• Patient Sequence Number: 1
• Treatment: TRAUMA TO UNK - INSERTION INSTRUMENTS: TRAUMA
• Patient Outcome(s): Required Intervention