MAUDE Adverse Event Report: SYNTHES GMBH 8.5MM TI MULTILOC HUMERAL NAIL LEFT/CANN/270MM-STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 04.019.270S

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/11/2022

Event Type  malfunction  

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2022, that while impacting the hn multiloc ø 8 nail in the proximal part, it was damaged and bent in the part where it connects to the aiming arm. It was decided to change it for the hn multiloc ø 7 nail. When the assistant opened the sealed box, it came with the metal packaging open, so factory sterility was no longer guaranteed. Due to this setback and due to the urgency of the specialist to go out for another procedure, the patient was not fitted with any device for fixation, so this weekend a second surgery is planned to perform the osteosynthesis. This report involves one (1) 8. 5mm ti multiloc humeral nail left/cann/270mm-sterile. This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation. Reporter is a j&j employee. 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.

• Brand Name: 8.5MM TI MULTILOC HUMERAL NAIL LEFT/CANN/270MM-STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13740374
• MDR Text Key: 289333401
• Report Number: 8030965-2022-01568
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K120807
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 04.019.270S
• Device Catalogue Number: 04.019.270S
• Device Lot Number: 98P5935
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 03/11/2022 Patient Sequence Number: 1

Treatment

MULTILOC HN Ø8.5 LE CANN L270; UNK - GUIDES/SLEEVES/AIMING: AIMING ARM; UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: TRAUMA