MAUDE Adverse Event Report: CARBOFIX ORTHOPEDICS LTD. PICCOLO COMPOSITE PROXIMAL HUMERUS PLATE; BONE PLATE

Catalog Number PPHNN3512

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/18/2020

Event Type  malfunction  

Manufacturer Narrative

The involved plate, within its double-pouch pack, was received at the company and inspected.Based on the examination, the implant was found to be in order, with smooth distal tip (no sharp edges).The distal end of the plate seemed to slightly penetrate the internal pouch sealing.Examination of the production records of the involved plate and its packaging did not reveal deviation from specification.Importantly, the sealing machine used to seal the pouches is validated in the beginning of each working day by performing seal strength test and seal integrity test.Additionally, each pouch is visually examined for sealing integrity following the sealing process.Specifically, the records indicate that the tests conducted at the day the involved product was packed met the tests acceptance criteria.Note: due to restrictions related to the coronavirus situation, the submission of this report was delayed.

Event Description

During operation in (b)(6), upon opening the packaging of the plate, it was noted that the pouch sealing was compromised.Another plate was used.

• Brand Name: PICCOLO COMPOSITE PROXIMAL HUMERUS PLATE
• Type of Device: BONE PLATE
• Manufacturer (Section D): CARBOFIX ORTHOPEDICS LTD.; 11 ha'hoshlim street; herzeliya, 46724 11; IS 4672411
• Manufacturer (Section G): CARBOFIX ORTHOPEDICS LTD.; 11 ha'hoshlim street; herzeliya, 46724 11; IS 4672411
• Manufacturer Contact: hila wachsler-avrahami ; 11 ha'hoshlim street; herzeliya, 46724-11 ; IS 4672411
• MDR Report Key: 10024868
• MDR Text Key: 189876043
• Report Number: 9615128-2020-00004
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K102597
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2023
• Device Catalogue Number: PPHNN3512
• Device Lot Number: 91638
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2020
• Date Manufacturer Received: 03/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1